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59 products found

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LIAISON®ANTI-HAV

310200
Intended Use For the qualitative detection of total IgG and IgM antibodies to Hepatitis A virus
Material provided Reagent integral for 100 determinations. Diluent included.
Method 2-step sandwich chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators Included
Sample Type Serum or Na+ Heparin plasma
Sample Size 80 µL
Comments In Vitro Diagnostic Use

LIAISON®Control Anti-HAV

310201
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON® HAV IgM

310210
Intended Use For the qualitative detection of IgM antibodies to Hepatitis A virus
Material provided Reagent integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic micropartles
Calibrators Included
Sample Type Serum or Na+ Heparin plasma
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control HAV IgM

310211
Material provided Two levels x 2 vials each 15 determinations per vial

LIAISON® Rubella IgG

310460
Intended Use For the qualitative determination of IgG antibodies to Rubella virus
Material provided Reagent integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic micropartles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Rubella IgG Tri-Controls

310461
Material provided Three levels x 2 vials each 15 determinations per vial

LIAISON® Rubella IgM

310730
Intended Use For the qualitative determination of IgM antibodies to Rubella virus
Material provided Reagent Integral for 100 determinations. Diluent included
Method Antibody capture immunoassay using coated magnetic microparticles
Calibrators Included
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control Rubella IgM

310732
Material provided Two levels x 2 vials each, 20 determinations total

LIAISON® Treponema Assay

310480
Intended Use For the qualitative determination of total antibodies to Treponema pallidum
Material provided Reagent Integral for 200 determinations. Diluent included
Method 1-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators Included
Incubation 30 minutes
Sample Type Serum
Sample Size 70 µL
Comments In Vitro Diagnostic Use

LIAISON® VZV IgG

310490
Intended Use For the qualitative determinations of IgG antibodies to Varicella-Zoster Virus
Material provided Reagent Integral for 50 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control VZV IgG

310491
Material provided Two levels x 2 vials each 20 determinations per vial

LIAISON® EBV IgM

310500
Intended Use For the qualitative determination of IgM antibodies to Epstein-Barr virus viral capsid antigen
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control EBV IgM

310501
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON®VCA IgG

310510
Intended Use For the qualitative determination of IgG antibodies to Epstein-Barr Virus Viral Capsid Antigen (VCA)
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic mircroparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control VCA IgG

310511
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON® EBNA IgG

310520
Intended Use For the qualitative determination of IgG antibodies to Epstein-Barr Virus Nuclear Antigen (EBNA-1)
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic mircroparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control EBNA IgG

310521
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON® EA IgG

310540
Intended Use For the qualitative determination of IgG antibodies to Epstein-Barr Virus Early Antigen (Diffuse) [EA(d)]
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control EA IgG

310541
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON® HSV-2 Type Specific IgG

310620
Intended Use For the qualitative determination of type specific IgG antibodies to Herpes Simplex Virus Type 2 (HSV-2)
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 5 µL
Comments In Vitro Diagnostic Use

LIAISON® Control HSV-2 Type Specific IgG

310621
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON® Toxo IgG II

310705
Intended Use For the qualitative determination of IgG antibodies to Toxoplasma gondii
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control Toxo IgG II

310706
Material provided Two levels x 2 vials each 24 determinations

LIAISON® Toxo IgM II

310715
Intended Use For the qualitative determination of IgM antibodies to Toxoplasma gondii
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators Included
Incubation 25 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control Toxo IgM II

310716
Material provided Two levels x 2 vials each 24 determinations

LIAISON® CMV IgG

310740
Intended Use For the qualitative determination of IgG antibodies to Cytomegalovirus
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control CMV IgG

310741
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON® CMV IgM

310750
Intended Use For the qualitative determination of IgM antibodies to Cytomegalovirus
Material provided Reagent integral for 100 determinations. Diluent included.
Method 3-step chemiluminescent immunoassay using directly coated magnetic microparticles
Calibrators Included
Incubation 30 minutes
Sample Type Serum
Sample Size 20 µL
Comments In Vitro Diagnostic Use

LIAISON® Control CMV IgM

310751
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON® HSV-1 Type Specific IgG

310830
Intended Use For the qualitative determination of type specific IgG antibodies to Herpes Simplex Virus Type 1 (HSV-1)
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 10 µL
Comments In Vitro Diagnostic Use

LIAISON® Control HSV-1 IgG

310831
Material provided Two levels x 2 vials each 40 determinations per vial

LIAISON® Treponema Serum Controls

310842
Material provided Two levels x 2 vials each 20 determinations per vial

LIAISON® Borrelia burgdorferi

310870
Intended Use For the qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi
Material provided Reagent Integral for 100 determinations. Diluent included
Method 2-step chemiluminescent immunoassay using coated magnetic microparticles
Calibrators Included
Incubation 20 minutes
Sample Type Serum
Sample Size 5 µL
Comments In Vitro Diagnostic Use

LIAISON® Borrelia burgdorferi Serum Controls

310871
Material provided Two levels x 2 vials each 40 determinations per vial

ETI-Measles IgG ELISA

4601/96 Wells
Intended Use For the semi-quantitative detection of IgG antibodies to Measles Virus
Label HRP
Incubation 30 min + 30 min + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum
Sample Size 100 µL of 1:101 dilution
Comments In Vitro Diagnostic Use

ETI-Varicella Zoster (VZV) IgG ELISA

4621/96 Wells
Intended Use For the qualitative and semi-qualitative detection of IgG antibodies to Varicella Zoster Virus
Label HRP
Incubation 30 min + 30 min + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum
Sample Size 100 µL of 1:101 dilution
Comments In Vitro Diagnostic Use

ETI-Mumps IgG ELISA

4631/96 Wells
Intended Use For the qualitative and semi-quantitative determination of IgG antibodies to Mumps Virus
Label HRP
Incubation 30 min + 30 min + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum
Sample Size 100 µL of 1:21 dilution
Comments In Vitro Diagnostic Use

ETI-H. pylori IgG

4651/96 Wells
Intended Use For the qualitative determination of IgG antibodies to H. pylori antigen
Label HRP
Incubation 30 min + 30 min + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum
Sample Size 100 µL of 1:21 dilution
Comments In Vitro Diagnostic Use

Cytomegalovirus (CMV) IgG ELISA

720-320/96 Wells
Intended Use For the qualitative and semi-quantitative detection of IgG antibodies to Cytomegalovirus
Label HRP
Incubation 60 + 60 + 20 min/37°C
Chromogen/Substrate TMB
Sample Type Serum
Sample Size 100 µL of 1:101 dilution
Comments In Vitro Diagnostic Use

Cytomegalovirus (CMV) IgM Capture ELISA

720-330/96 Wells
Intended Use For the qualitative detection of IgM antibodies to CMV
Label HRP
Incubation 60 + 60 + 20 min/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum
Sample Size 100 µL of 1:101 dilution
Comments In Vitro Diagnostic Use

HSV 1&2 IgG ELISA

720-340/96 Wells
Intended Use For qualitative and semi-quantitative detection of IgG antibodies to HSV Type 1 and/or Type 2
Label HRP
Incubation 60 min + 60 min + 20 min/37°C
Chromogen/Substrate TMB
Sample Type Serum
Sample Size 100 µL of 1:101 dilution
Comments In Vitro Diagnostic Use

Ortho® HCV 3.0 ELISA

930740/480 Wells
Intended Use For the detection of antibody to Hepatitis C Virus (anti-HCV)
Label HRP
Incubation 1 hr/37°C + 1 hour/37°C + 30 min/RT
Chromogen/Substrate OPD
Sample Type Serum/Plasma
Sample Size 210 µL of 1:21 dilution
Comments In Vitro Diagnostic Use

HBsAg Confirmatory PLUS

N0143/44 Tests
Intended Use Confirmatory assay for Hepatitis B Surface Antigen (HBsAg)
Sample Type Serum/Plasma
Comments In Vitro Diagnostic Use

ETI-HA-IgMK PLUS (IgM anti-HAV)

P001925/96 Wells
Intended Use For the detection of IgM antibodies to Hepatitis A virus
Label HRP
Incubation 2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum/Plasma
Sample Size 100 µL of 1:100 dilution
Comments In Vitro Diagnostic Use

ETI-AB-HAVK PLUS (anti-HAV)

P001926/96 Wells
Intended Use For the detection of total antibodies to Hepatitis A virus
Label HRP
Incubation 2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum/Plasma
Sample Size 50 µL
Comments In Vitro Diagnostic Use

ETI-AB-COREK PLUS (anti-HBc)

P001927/192 Wells
Intended Use For the detection of total antibodies to Hepatitis B core antigen (anti-HBc)
Label HRP
Incubation 2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum/Plasma
Sample Size 50 µL
Comments In Vitro Diagnostic Use

ETI-CORE-IgMK PLUS (IgM anti-HBc)

P001928/96 Wells
Intended Use For the detection of IgM antibodies to Hepatitis B core antigen (IgM anti-HBc)
Label HRP
Incubation 2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum/Plasma
Sample Size 100 µL of (1:4000) dilution
Comments In Vitro Diagnostic Use

ETI-AB-EBK PLUS (anti-HBe)

P001929/96 Wells
Intended Use For the detection of antibodies to Hepatitis B(e) antigen (AntiHBe)
Label HRP
Incubation 2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum/Plasma
Sample Size 50 µL
Comments In Vitro Diagnostic Use

ETI-EBK PLUS (HBeAg)

P001930/96 Wells
Intended Use For the detection of Hepatitis B(e) antigen (HBeAg)
Label HRP
Incubation 2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum/Plasma
Sample Size 100 µL
Comments In Vitro Diagnostic Use

ETI-AB-AUK PLUS (anti-HBs)

P001931/192 Wells
Intended Use For the detection of antibodies to Hepatitis B surface antigen (anti-HBs)
Label HRP
Incubation 2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum/Plasma
Sample Size 100 µL
Comments In Vitro Diagnostic Use

ETI-MAK-2 PLUS (HBsAg)

P001932/192 Wells
Intended Use For the detection of Hepatitis B surface antigen (HBsAg)
Label HRP
Incubation 2 hrs/37°C + 1 hr/37°C + 30 min/RT
Chromogen/Substrate TMB
Sample Type Serum/Plasma
Sample Size 100 µL
Comments In Vitro Diagnostic Use

Anti-HBs Quant AB AU Standard Set

P001936
Intended Use Standard set anti-HBs (5-160 mIU/mL; WHO 1st reference preparation 1977)
Sample Type Serum/Plasma
Comments ASR: Analyte Specific Reagent analytical and performance characteristics are not established. Not for donor screening

TREP-SURE™ Syphilis Screen

TS96/96 Wells
Intended Use For the in vitro diagnostic detection of (Treponema pallidum) Antibodies (Syphilis)
Label HRP
Incubation 60 min + 30 min + 15 min/37°C
Chromogen/Substrate TMB
Sample Type Serum or EDTA and Citrated Plasma
Sample Size 100 µL
Comments In Vitro Diagnostic Use

LIAISON® QuantiFERON® -TB Gold Plus

311020
Intended Use The LIAISON® QuantiFERON®-TB Gold Plus assay is an in vitro diagnostic test for the detection of interferon-γ (IFN-γ) in human lithium heparin plasma by chemiluminescence immunoassay (CLIA) using the LIAISON® XL Analyzer. QIAGEN QuantiFERON®-TB Gold Plus Blood Collection Tubes, containing a peptide cocktail simulating ESAT-6 and CFP-10 proteins, are used in conjunction with the LIAISON® QuantiFERON®-TB Gold Plus assay to stimulate cells in heparinized whole blood. Detection of IFN-γ is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection. The assay is a qualitative indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations to assist the clinician in making individual patient management decisions. The LIAISON® QuantiFERON®-TB Gold Plus assay must be performed using the LIAISON® XL Analyzer.
Material provided Reagent integral for 200 determinations, 50 patients
Method Direct sandwich: monoclonal antibodies to IFN-γ coated on magnetic particles and monoclonal antibodies to IFN-γ linked to an isoluminol derivative isoluminol-antibody conjugate
Calibrators Included, lyophilized
Sample Type Human Lithium Heparin Plasma (QIAGEN QuantiFERON®-TB Gold Plus Blood Collection Tubes)

LIAISON® Control QuantiFERON® -TB Gold Plus

311021
Intended Use The LIAISON® Control QuantiFERON®-TB Gold Plus is intended for use as assayed quality control samples to monitor the performance of the LIAISON® QuantiFERON®-TB Gold Plus assay. The performance characteristics of LIAISON® Control QuantiFERON®-TB Gold Plus have not been established for any other assays or instrument platforms other than LIAISON® XL Analyzer.
Material provided Control level 1 (lyophilized, 2 x 2.0 mL); Control level 2 (lyophilized, 2 x 2.0 mL)

LIAISON® SARS-CoV-2 S1/S2 IgG

311460
Intended Use For qualitative determination of anti-S1 and anti-S2 specific IgG antibodies to SARS-CoV-2

“This test has not been FDA cleared or approved;
  • • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • • This test has been authorized only for the presence of IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
  • • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. “
Material provided Reagent Integral for 110 determinations.
Method Indirect chemiluminescence immunoassay (CLIA)
Calibrators Included
Sample Type Serum or plasma (sodium heparin, lithium heparin, and potassium EDTA)

LIAISON® SARS-CoV-2 S1/S2 IgG Control set

311461
Material provided Sufficient for 40 determinations
Sample Type Serum or plasma

LIAISON® SARS-CoV-2 IgM

311480
Intended Use For qualitative determination of specific IgM antibodies to SARS-CoV-2

“This test has not been FDA cleared or approved;
  • • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • • This test has been authorized only for the presence of IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
  • • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. “
Material provided Reagent Integral for 110 determinations.
Method Indirect chemiluminescence immunoassay (CLIA)
Calibrators Included
Sample Type Human serum or plasma samples (sodium heparin, lithium heparin, and dipotassium EDTA)

LIAISON® Control SARS-CoV-2 IgM

311481
Material provided Sufficient for 40 determinations