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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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

Citrate Buffer - M52551210

No Description
HELENA LABORATORIES CORPORATION
5121
In Commercial Distribution

  • M52551210 ()


  • Protein electrophoresis IVD, reagent

SPIFE IgG IEF-20 Kit - M52533850

No Description
HELENA LABORATORIES CORPORATION
3385
In Commercial Distribution

  • M52533850 ()


  • Protein electrophoresis IVD, kit, electrophoresis

V8 Nexus CE Analyzer (115V/230V) - M52518250000

No Description
HELENA LABORATORIES CORPORATION
1825000
In Commercial Distribution

  • M52518250000 ()


  • Electrophoresis analyser IVD

V8 Gel IFE Diluent Barcode Labels - M52518210

No Description
HELENA LABORATORIES CORPORATION
1821
In Commercial Distribution

  • M52518210 ()


  • Protein electrophoresis IVD, reagent

V8 WASTE DRAWER PACK - M52518200

No Description
HELENA LABORATORIES CORPORATION
1820
In Commercial Distribution

  • M52518200 ()


  • Electrophoresis analyser IVD

V8 Immunodisplacement Kit - M52518030

No Description
HELENA LABORATORIES CORPORATION
1803
In Commercial Distribution

  • M52518030 ()


  • Protein electrophoresis IVD, reagent

V8 E-Class Velocity CE Analyzer (220V) - M52518010000

No Description
HELENA LABORATORIES CORPORATION
1801000
In Commercial Distribution

  • M52518010000 ()


  • Electrophoresis analyser IVD

V8 Velocity CE Analyzer (110V) Inpeco Ready - M52518000010

No Description
HELENA LABORATORIES CORPORATION
1800001
In Commercial Distribution

  • M52518000010 ()


  • Electrophoresis analyser IVD

V8 Velocity CE Analyzer (110V) Not Inpeco Ready - M52518000000

No Description
HELENA LABORATORIES CORPORATION
1800000
In Commercial Distribution

  • M52518000000 ()


  • Electrophoresis analyser IVD

QuickGel Disposable IFE Sample Cup Strips - M52512580

No Description
HELENA LABORATORIES CORPORATION
1258
In Commercial Distribution

  • M52512580 ()


  • Protein electrophoresis IVD, kit, electrophoresis

Hydrashift 2 4 isatuximab - 03607360046425

No Description
SEBIA
4642
In Commercial Distribution

  • 03607360046425 ()
4642

  • Multiple clinical chemistry protein IVD, reagent

HYDRASHIFT 2 4 daratumumab 20 tests - 03607360046395

No Description
SEBIA
4639
In Commercial Distribution

  • 03607360046395 ()
4639

  • Multiple clinical chemistry protein IVD, reagent

Sample Diluent CAPI 3 IT (10) - 03607360026021

No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent

ANTISERA CAPI 3 IT (10) - 03607360026014

No Description
SEBIA
2601
In Commercial Distribution

  • 03607360026014 ()
2601

  • Multiple clinical chemistry protein IVD, reagent

PneumoTrol - 00847661002734

PneumoTrol (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00129
In Commercial Distribution

  • 00847661002734 ()
00129

  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, control
  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, control
  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control

DG Gel 8 T/S Mono - 08437014205053

The DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210391
Not in Commercial Distribution

  • 08437014205053 ()
210391

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

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)

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® 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

NA - 05032384005888

No Description
OXOID LIMITED
CT0043B
In Commercial Distribution

  • 05032384005888 ()
  • 05032384502530 ()


  • Penicillin G susceptibility testing disc IVD

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

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)

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

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
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