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SPIFE ImmunoFix-6 Antisera Kit - M5255518220

No Description
HELENA LABORATORIES CORPORATION
551822
In Commercial Distribution

  • M5255518220 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE ImmunoFix-3/6 Applicator Kit - M5255517160

No Description
HELENA LABORATORIES CORPORATION
551716
In Commercial Distribution

  • M5255517160 ()


  • Protein electrophoresis IVD, kit, electrophoresis

VersaPump Infuser - 00817708023404

The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).
EMED TECHNOLOGIES CORPORATION
FP-0010209
In Commercial Distribution

  • 00817708023404 ()
FP-0010209

  • Ambulatory non-insulin infusion pump, mechanical, reusable

SCIg60 - 00817708023398

SCIg60 Infusion Pump Carrying Case
EMED TECHNOLOGIES CORPORATION
FP-0010032
In Commercial Distribution

  • 00817708023398 ()


  • Ambulatory non-insulin infusion pump, mechanical, reusable

SCIg60 Infusion System - 00817708020274

SCIg60 Infuser (Mechanical Pump) Assembly
EMED TECHNOLOGIES CORPORATION
FP-0010002
In Commercial Distribution

  • 00817708020274 ()
FP-0010002

  • Ambulatory non-insulin infusion pump, mechanical, reusable

K-ASSAY® IgM Reagent - 00816426020115

For the quantitative determination of human IgM in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-015
In Commercial Distribution

  • 00816426020115 ()
KAI-015

  • Total immunoglobulin M (IgM total) IVD, reagent

K-ASSAY® IgA Reagent - 00816426020092

For the quantitative determination of human IgA in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-013
In Commercial Distribution

  • 00816426020092 ()
KAI-013

  • Total immunoglobulin A (IgA total) IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638 - 00817302020953

IgM (Immunoglobulin M) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC638
Not in Commercial Distribution

  • 00817302020953 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 23 Milliliter
CC638

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516749138

T. pallidum WB IgG Positive Control, 250µl
MARDX DIAGNOSTICS, INC.
40-5023
In Commercial Distribution

  • 05391516749138 ()
40-5023

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control

Trinity Biotech - 05391516749121

T. pallidum WB Negative Control, 250µl
MARDX DIAGNOSTICS, INC.
40-5021
In Commercial Distribution

  • 05391516749121 ()
40-5021

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control

Trinity Biotech - 05391516746328

Uni-Gold™ Giardia, 20 Tests
MARDX DIAGNOSTICS, INC.
1206610
In Commercial Distribution

  • 05391516746328 ()
1206610

  • Giardia lamblia immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

ePlex System - 00857167005016

Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

TPHA Screen Positive Control and TPHA Screen Negative Control - 10888234001508

TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen on an automated Blood Bank system. The product configuration is one (1) vial of each control.
IMMUCOR, INC.
0066828
In Commercial Distribution

  • 10888234001508 ()
0066828

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control

PK7400 TP HA CONTROLS - 05060515140047

PK7400 TP HA CONTROLS is intended for use with the PK7400 TP HA REAGENT (B11186) for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies in human serum, EDTA plasma and CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System.
NEWMARKET BIOMEDICAL LIMITED
B11187
In Commercial Distribution

  • 05060515140047 ()

  • 16 x 5mL


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control

IFA HSV-1 IgG Test System - 00845533001557

The ZEUS IFA Herpes Simplex Virus-1 (HSV-1) IgG Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (IFA) technique and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9051G
In Commercial Distribution

  • 00845533001557 ()
FA9051G

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA T. gondii IgG Test System - 00845533001519

The ZEUS IFA Toxoplasma gondii IgG Test System is designed to detect the presence of circulating T. gondii antibodies in human sera and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
ZEUS SCIENTIFIC, INC.
FA8001G
In Commercial Distribution

  • 00845533001519 ()
FA8001G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Alinity - 00380740131357

Alinity i HAVAb IgG Calibrator
Abbott GmbH
08P2701
In Commercial Distribution

  • 00380740131357 ()
08P2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740011161

ARCHITECT HAVAB-G Calibrator
Abbott GmbH
6L27-01
In Commercial Distribution

  • 00380740011161 ()
06L2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator

Alinity - 00380740197704

HSV-1 IgG Reagent Kit 200 Tests
Abbott Ireland Diagnostics
04W2027
In Commercial Distribution

  • 00380740197704 ()
04W2027

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Alinity - 00380740197636

HAVAb IgG II Calibrator
Abbott GmbH
06S9301
In Commercial Distribution

  • 00380740197636 ()
06S9301

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator

Alinity - 00380740174361

Alinity i Toxo IgG Reagent Kit (1000T)
Abbott GmbH
07P4545
In Commercial Distribution

  • 00380740174361 ()
07P4545

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Alinity - 00380740174354

Alinity i Toxo IgG Reagent Kit (200T)
Abbott GmbH
07P4540
In Commercial Distribution

  • 00380740174354 ()
07P4540

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

AESKULISA® ASCA-G - 04250289503150

AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Aesku.Diagnostics GmbH & Co. KG
7508US
In Commercial Distribution

  • 04250289503150 ()
7508US

  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)

AESKULISA® ASCA-G - 04250289502900

AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease. 30'+30'+30' automation incubation.
Aesku.Diagnostics GmbH & Co. KG
30-7508US
In Commercial Distribution

  • 04250289502900 ()
30-7508US

  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)

AESKULISA® ASCA-G - 04250289501538

AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Aesku.Diagnostics GmbH & Co. KG
3508
In Commercial Distribution

  • 04250289501538 ()


  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)

ImmunoFA Toxoplasma IgG - 00613745012001

The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii in human serum. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Genbio
800-1200
In Commercial Distribution

  • 00613745012001 ()

  • 100 tests
1200

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Aspergillus fumigatus IgG ELISA - 00404847461299

The Aspergillus fumigatus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Aspergillus fumigatus in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6129
Not in Commercial Distribution

  • 00404847461299 ()
EIA-6129

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

RSV IgG ELISA - 00404847435078

The DRG RSV IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Respiratory Syncytial Virus (RSV) in serum. This assay is intended for in vitro diagnostic use only.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3507
Not in Commercial Distribution

  • 00404847435078 ()
EIA-3507

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Aspergillus fumigatus IgG ELISA - 00404847425017

Enzyme immunassay for the qualitative and quantitative determination of IgG antibodies against Aspergillus fumigatus in human serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2501
Not in Commercial Distribution

  • 00404847425017 ()
EIA-2501

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Atellica IM Herpes-2 IgG - 00842768022807

Herpes-2 IgG (HSV2) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10733033
In Commercial Distribution

  • 00842768022807 ()
10733033

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Atellica IM Herpes-1 IgG - 00842768022784

Herpes-1 IgG (HSV1) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10733031
In Commercial Distribution

  • 00842768022784 ()
10733031

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

MONOLISA™ - 00847865013178

Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26203
In Commercial Distribution

  • 00847865013178 ()

  • Total Volume: 1.5 Milliliter
26203

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

Autoimmune EIA - 00847817018541

Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgG
BIO-RAD LABORATORIES, INC.
425-2340
In Commercial Distribution

  • 00847817018541 ()

  • 96 Tests
4252340

  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)

NA - 05032384005888

No Description
OXOID LIMITED
CT0043B
In Commercial Distribution

  • 05032384005888 ()
  • 05032384502530 ()


  • Penicillin G susceptibility testing disc IVD

ADVIA Centaur® Toxo G - 00630414208459

Toxoplasma IgG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310321
In Commercial Distribution

  • 00630414208459 ()
120154

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Atellica IM Toxo G - 00630414600123

Toxoplasma G - IgG (ToxG) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995699
In Commercial Distribution

  • 00630414600123 ()
10995699

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems TXP Toxoplasma Quantitative IgG - 00630414964805

Toxoplasma IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381268
In Commercial Distribution

  • 00630414964805 ()
LKTXP1

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems TXP Toxoplasma Quantitatve IgG - 00630414962238

Toxoplasma IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381323
In Commercial Distribution

  • 00630414962238 ()
L2KTXP2

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur Herpes-1 IgG - 00630414016740

Herpes-1 IgG (HSV1) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720846
In Commercial Distribution

  • 00630414016740 ()
10720846

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur Herpes-2 IgG - 00630414016726

Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720849
In Commercial Distribution

  • 00630414016726 ()
10720849

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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