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C. DIFF QUIK CHEK - 00857031002141

The C. DIFF QUIK CHEK test is a rapid membrane enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
30390
In Commercial Distribution

  • 00857031002141 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF CHEK - 60 - 00857031002110

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with patient history.
TECHLAB, INC.
30392
In Commercial Distribution

  • 00857031002110 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFFICILE TOX A/B II - 00857031002103

The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
30397
In Commercial Distribution

  • 00857031002103 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF QUIK CHEK COMPLETE - 00857031002059

The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
T30525C
In Commercial Distribution

  • 00857031002059 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

TOX A/B QUIK CHEK - 00857031002042

The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium difficile toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
30394
In Commercial Distribution

  • 00857031002042 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFFICILE TOX A/B II - 00857031002646

The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
T5015XB
In Commercial Distribution

  • 00857031002646 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF QUIK CHEK COMPLETE - 00857031002554

The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
T5038
Not in Commercial Distribution

  • 00857031002554 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF CHEK - 60 - 00857031002448

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with patient history.
TECHLAB, INC.
30392B
In Commercial Distribution

  • 00857031002448 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFFICILE TOX A/B II - 00857031002431

The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
30397B
In Commercial Distribution

  • 00857031002431 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFFICILE TOX A/B II - 00857031002424

The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
T5015B
In Commercial Distribution

  • 00857031002424 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF QUIK CHEK COMPLETE - 00857031002387

The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
30550C
In Commercial Distribution

  • 00857031002387 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF QUIK CHEK COMPLETE - 00857031002370

The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
30525C
In Commercial Distribution

  • 00857031002370 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

TOX A/B QUIK CHEK - 00857031002257

The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium difficile toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
T5033
In Commercial Distribution

  • 00857031002257 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

cobas® HBV/HCV/HIV-1 Control Kit - 00875197006476

No Description
Roche Molecular Systems, Inc.
09040773190
In Commercial Distribution

  • 00875197006476 ()
09040773190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

cobas® MPX Control Kit - 00875197004847

No Description
Roche Diagnostics GmbH
06999069190
In Commercial Distribution

  • 00875197004847 ()
06999069190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

cobas® HBV/HCV/HIV-1 Control Kit - 00875197004748

No Description
Roche Diagnostics GmbH
1.0
In Commercial Distribution

  • 00875197004748 ()
06998887190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

cobas® TaqScreen MPX Control Kit, v2.0 - 00875197004014

No Description
Roche Molecular Systems, Inc.
2.0
In Commercial Distribution

  • 00875197004014 ()
05965390190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

cobas® TaqScreen Cadaveric Specimen Diluent Kit - 00875197002676

No Description
Roche Molecular Systems, Inc.
05002125190
In Commercial Distribution

  • 00875197002676 ()
05002125190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

cobas® TaqScreen MPX Control Kit - 00875197001754

No Description
Roche Molecular Systems, Inc.
04626303190
In Commercial Distribution

  • 00875197001754 ()
04626303190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit - 00875197001051

No Description
Roche Molecular Systems, Inc.
03302555018
In Commercial Distribution

  • 00875197001051 ()
03302555018

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Trinity Biotech - 05391516747998

Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent

Trinity Biotech - 05391516747950

Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests
MARDX DIAGNOSTICS, INC.
B1029-70
In Commercial Distribution

  • 05391516747950 ()
B1029-70

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

ACCURUN® - 00816784020628

ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0105
In Commercial Distribution

  • 00816784020628 ()

  • Total Volume: 20 Milliliter
2020-0105

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

ACCURUN® - 00816784020611

ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0104
In Commercial Distribution

  • 00816784020611 ()

  • Total Volume: 5 Milliliter
2020-0104

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

VisuLize Factor FIX Antigen Kit - 10629009020009

96 Test enzyme immunoassay kit for the determination of FIX Antigen
Affinity Biologicals Inc
FIX-AG
In Commercial Distribution



  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)

Tinto Hepatitis B Virus Core Antigen RPab - B502BSB56150

HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB56150 ()
BSB 5615

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent

Tinto Hepatitis B Virus Core Antigen RPab - B502BSB56140

HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB56140 ()
BSB 5614

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent

Tinto Hepatitis B Virus Core Antigen RPab - B502BSB56130

HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB56130 ()
BSB 5613

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent

Tinto Hepatitis B Virus Core Antigen, RPab - B502BSB56120

Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB56120 ()
BSB 5612

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent

Tinto Hepatitis B Virus Core Antigen, RPab - B502BSB56110

Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB56110 ()
BSB 5611

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent

Tinto Hepatitis B Virus Core Antigen, RPab - B502BSB56100

Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56100 ()
BSB 5610

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent

VIDAS® C. difficile GDH - 03573026444204

VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen
BIOMERIEUX SA
30125-01
In Commercial Distribution

  • 03573026444204 ()


  • Clostridium difficile antigen IVD, antibody

VIDAS® C. difficile Toxin A & B - 03573026229146

The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens
BIOMERIEUX SA
30118-01
In Commercial Distribution

  • 03573026229146 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

Amplichek - 03610520530092

Amplichek I MiniPak (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000531
In Commercial Distribution

  • 03610520530092 ()
12000531

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Amplichek - 03610520530085

Amplichek I Level 3 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000530
In Commercial Distribution

  • 03610520530085 ()
12000530

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Amplichek - 03610520530078

Amplichek I Level 2 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000529
In Commercial Distribution

  • 03610520530078 ()
12000529

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Amplichek - 03610520530061

Amplichek I Level 1 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000528
In Commercial Distribution

  • 03610520530061 ()
12000528

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Amplichek - 03610520530054

Amplichek I Negative (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000527
In Commercial Distribution

  • 03610520530054 ()
12000527

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Asserachrom® IX:Ag - 03607450009439

No Description
DIAGNOSTICA STAGO
00943
In Commercial Distribution

  • 03607450009439 ()


  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)

ImmunoCard C. difficile GDH - 00840733101793

ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
MERIDIAN BIOSCIENCE, INC.
716050
In Commercial Distribution

  • 00840733101793 ()
716050

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

ImmunoCard Toxins A & B - 00840733101786

ImmunoCard Toxins A & B is a rapid, qualitative, horizontal-flow enzyme immunoassay (EIA) for detecting Clostridium difficile Toxins A and B in human stool. This assay is used as an aid in the diagnosis of C. difficile-associated disease. In the US, ImmunoCard Toxins A & B is not intended for point-of-care use. The device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.
MERIDIAN BIOSCIENCE, INC.
712050
In Commercial Distribution

  • 00840733101786 ()
712050

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

PREMIER Toxins A and B - 00840733101694

Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic-associated diarrhea. Premier Toxins A&B is intended for use as an aid in the diagnosis of C. difficile associated disease (CDAD).
MERIDIAN BIOSCIENCE, INC.
616096
In Commercial Distribution

  • 00840733101694 ()
616096

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

PREMIER C. difficile GDH - 00840733101687

Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
MERIDIAN BIOSCIENCE, INC.
611096
In Commercial Distribution

  • 00840733101687 ()
611096

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

Rabbit Monoclonal Anti-Human Guanine deaminase (GDA) (EP407) - 00810138720332

Rabbit Monoclonal Anti-Human Guanine deaminase (GDA) (EP407), concentrated
Epitomics Inc.
AC-0373BULK
In Commercial Distribution

  • 00810138720332 ()


  • Clostridium difficile antigen IVD, antibody

Rabbit Monoclonal Anti-Human Guanine deaminase (GDA) (EP407) - 00810138720325

Rabbit Monoclonal Anti-Human Guanine deaminase (GDA) (EP407), 0.5mL concentrated
Epitomics Inc.
AC-0373B
In Commercial Distribution

  • 00810138720325 ()

  • Total Volume: 0.5 Milliliter


  • Clostridium difficile antigen IVD, antibody

Status Flu Controls - 10743816001423

Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution

  • 10743816001423 ()
BSP-510C-02

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control

BioSign Flu Controls - 10743816001492

BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution

  • 10743816001492 ()
BSP-510C-03

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control

OraSure QuickFlu Positive and Negative Control Kit - 00608337000054

No Description
Orasure Technologies, Inc.
1001-0323
In Commercial Distribution

  • 00608337000054 ()


  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR - 00840828100847

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-991-144
In Commercial Distribution

  • 00840828100847 ()
229

  • Electrical mains power extension cable

CD39 [EPR20627] - 00847627030580

No Description
BIOCARE MEDICAL LLC
AVI3283G
In Commercial Distribution

  • 00847627030580 ()


  • Niemann-Pick disease (SMPD1-associated) IVD, kit, nucleic acid technique (NAT)
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