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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

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

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

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

QUANTA Lite® ASCA IgG ELISA - 08426950514206

(S. cerevisiae) 1. 1x ASCA IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgG ELISA Low Positive 4. 1x 1.2mL prediluted ASCA IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708865
In Commercial Distribution

  • 08426950514206 ()


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

LIAISON® HSV-1 Type Specific IgG - 08056771600231

No Description
Diasorin Inc.
310830
In Commercial Distribution

  • 08056771600231 ()
  • 18056771600238 ()


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

HSV-2 IgG Test System, 120 Tests - B110HS2G1200

No Description
Bion Enterprises, Ltd.
HS2G-120
In Commercial Distribution

  • B110HS2G1200 ()
HS2G-120

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

HSV-1 IgG Test System, 120 Tests - B110HS1G1200

No Description
Bion Enterprises, Ltd.
HS1G-120
In Commercial Distribution

  • B110HS1G1200 ()
HS1G-120

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

COOLIEF* Cooled RF Introducer - 10680651442083

Coolief* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
44208
In Commercial Distribution

  • 10680651442083 ()
CRI-17-100-4

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator

COOLIEF* Cooled RF Introducer - 10680651442076

Coolief* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
44207
In Commercial Distribution

  • 10680651442076 ()
CRI-17-75-5.5

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator

CHORUS RESPIRATORY SYNCYTIAL VIRUS IgG - 08033891327668

No Description
DIESSE DIAGNOSTICA SENESE SPA
81036
In Commercial Distribution

  • 08033891327668 ()
81036

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

ACCURUN® - 00816784020284

ACCURUN 115 Hepatitis B Core IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0070
In Commercial Distribution

  • 00816784020284 ()
2015-0070

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

HardyDisk™ - 00816576020898

Penicillin 10μg (P10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8885
In Commercial Distribution

  • 00816576020898 ()
  • 00816576021710 ()
Z8885

  • Penicillin G susceptibility testing disc IVD

HardyDisk™ - 00816576020881

Penicillin 10μg (P10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8881
In Commercial Distribution

  • 00816576020881 ()
  • 00816576021710 ()
Z8881

  • Penicillin G susceptibility testing disc IVD

Diamedix - 00817273020143

"720-310 Toxoplasma IgM Test Kit"
DIAMEDIX CORPORATION
720-310
In Commercial Distribution

  • 00817273020143 ()


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

Diamedix - 00817273020136

"720-300 Toxoplasma IgG Test Kit"
DIAMEDIX CORPORATION
720-300
In Commercial Distribution

  • 00817273020136 ()


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

Aspergillus fumigatus IgG ELISA - 07640158216101

The Aspergillus fumigatus ELISA test is a qualitative enzyme immunoassay for the detection of Aspergillus fumigatus antibodies in human serum samples.
Bordier affinity products S.A.
6100
In Commercial Distribution

  • 07640158216101 ()
6100

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

ASI Rubella Test Control Set - 00816057021635

Detection of Rubella Virus Antibodies
ARLINGTON SCIENTIFIC, INC.
NC-605001
In Commercial Distribution

  • 00816057021635 ()

  • Total Volume: 1 Milliliter
NC-605001

  • Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, control

LIAISON® Toxo IgG II - 08056771100762

No Description
DIASORIN SPA
310705
In Commercial Distribution

  • 08056771100762 ()


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

ARCHITECT - 00380740011161

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

  • 00380740011161 ()
06L2701

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