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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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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)

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

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

LIAISON® Toxo IgG II - 08056771100762

No Description
DIASORIN SPA
310705
In Commercial Distribution

  • 08056771100762 ()


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

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)

RSV IgG ELISA - 00840239035073

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.
DRG International Inc
EIA-3057
In Commercial Distribution

  • 00840239035073 ()
EIA-3057

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

Candida albicans IgG ELISA - 00840239034588

The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum.
DRG International Inc
EIA-3458
In Commercial Distribution

  • 00840239034588 ()

  • Stop Solution
  • Total Volume: 30 Milliliter
  • Wash Solution
  • Enzyme Conjugate
  • Sample Diluent
  • Total Volume: 14 Milliliter
  • Total Volume: 20 Milliliter
  • Substrate Solution
  • Positive Control
  • Negative Control
  • Cut-off Control
  • Total Volume: 2 Milliliter
  • Total Volume: 100 Milliliter
EIA-3458

  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Aspergillus fumigatus IgG ELISA - 00840239061294

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 International Inc
EIA-6129
In Commercial Distribution

  • 00840239061294 ()
EIA-6129

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

COOLIEF* - 00193493442102

COOLIEF* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
CRI-17-150-6
In Commercial Distribution

  • 10193493442109 ()
  • 00193493442102 ()
CRI-17-150-6

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

Anti-Schistosoma mansoni IFA (IgG) - 04049016101727

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2300-1005 G
In Commercial Distribution

  • 04049016101727 ()


  • Schistosoma mansoni immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-RSV ELISA (IgG) - 04049016028239

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2670-9601 G
In Commercial Distribution

  • 04049016028239 ()


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

Elecsys Toxo IgG - 04015630940301

No Description
Roche Diagnostics GmbH
07028008190
In Commercial Distribution

  • 04015630940301 ()
07028008190

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

Elecsys Toxo IgG Immunoassay - 04015630939336

No Description
Roche Diagnostics GmbH
4618815160
In Commercial Distribution

  • 04015630939336 ()
4618815160

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

Aspergillus fumigatus IgG ELISA - 04048474061291

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
In Commercial Distribution

  • 04048474061291 ()
EIA-6129

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

RSV IgG ELISA - 04048474035070

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.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3507
In Commercial Distribution

  • 04048474035070 ()
EIA-3507

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

Candida albicans IgG ELISA - 04048474034585

The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3458
In Commercial Distribution

  • 04048474034585 ()
EIA-3458

  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

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)

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

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

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

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

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

HSV 2 10 Well; 10 pk - 00813545025731

No Description
SCIMEDX CORPORATION
I-HV201X
In Commercial Distribution

  • 00813545025731 ()
I-HV201X

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

HSV 2 IgG 120 Test Kit - 00813545025717

No Description
SCIMEDX CORPORATION
I-HV201G
In Commercial Distribution

  • 00813545025717 ()
I-HV201G

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

HSV 1 10 Well; 10 pk - 00813545025700

No Description
SCIMEDX CORPORATION
I-HV101X
In Commercial Distribution

  • 00813545025700 ()
I-HV101X

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

HSV 1 IgG 120 Test Kit - 00813545025687

No Description
SCIMEDX CORPORATION
I-HV101G
In Commercial Distribution

  • 00813545025687 ()
I-HV101G

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

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

Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit - G5229025011

For the detection and titration of HSV-1 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902501
In Commercial Distribution

  • G5229025011 ()


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

Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test - G5229025001

For the detection and titration of HSV-1 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902500
In Commercial Distribution

  • G5229025001 ()


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

Toxo IgG IFA Slide Only Kit - G5229020211

For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
902021
In Commercial Distribution

  • G5229020211 ()


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

Toxo IgG IFA 204 Test - G5229020201

For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
902020
In Commercial Distribution

  • G5229020201 ()


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

Toxo IgG IFA 120 Test - G5229020101

For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
902010
In Commercial Distribution

  • G5229020101 ()


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

Access Toxo IgG - 15099590624927

The Access Toxo IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
A31588
In Commercial Distribution

  • 15099590624927 ()
A31588

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

Access Toxo IgG Calibrators - 15099590624910

The Access Toxo IgG Calibrators are intended to calibrate the Access Toxo IgG assay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
A31589
In Commercial Distribution

  • 15099590624910 ()
A31589

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

Access Toxo IgG QC - 15099590624903

The Access Toxo IgG QC is intended for monitoring system performance of the Access Toxo IgG assay.
Beckman Coulter, Inc.
A31590
In Commercial Distribution

  • 15099590624903 ()
A31590

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

NovaLisa Respiratory Syncytial Virus IgG - ENTIRSVG03800

The Respiratory Syncytial Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against respiratory syncytial virus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
RSVG0380
In Commercial Distribution

  • ENTIRSVG03800 ()
RSVG0380

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

ELISA HSV-2 IgG Smart Kit Test System - 00845533000758

The ZEUS ELISA Herpes Simplex Virus-2 (HSV-2) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9751G
In Commercial Distribution

  • 00845533000758 ()
SM9Z9751G

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

ELISA HSV-2 IgG Test System - 00845533000741

The ZEUS ELISA Herpes Simplex Virus-2 (HSV-2) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9751G
In Commercial Distribution

  • 00845533000741 ()
9Z9751G

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

ELISA HSV-1 IgG Smart Kit Test System - 00845533000734

The ZEUS ELISA Herpes Simplex Virus-1 (HSV-1) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9701G
In Commercial Distribution

  • 00845533000734 ()
SM9Z9701G

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

ELISA HSV-1 IgG Test System - 00845533000727

The ZEUS ELISA Herpes Simplex Virus-1 (HSV-1) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9701G
In Commercial Distribution

  • 00845533000727 ()
9Z9701G

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

ELISA HSV gG-2 IgG Smart Kit Test System - 00845533000697

The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
SM9Z9781G
In Commercial Distribution

  • 00845533000697 ()
SM9Z9781G

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

ELISA HSV gG-2 IgG Test System - 00845533000680

The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
9Z9781G
In Commercial Distribution

  • 00845533000680 ()
9Z9781G

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

ELISA HSV gG-1 IgG Smart Kit Test System - 00845533000673

The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
SM9Z9761G
In Commercial Distribution

  • 00845533000673 ()
SM9Z9761G

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

ELISA HSV gG-1 IgG Test System - 00845533000666

The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
9Z9761G
In Commercial Distribution

  • 00845533000666 ()
9Z9761G

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

AccuDiag ™ - 00850049545662

AccuDiag ™Toxoplasma (Toxo) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to Toxoplasma in human sera
Diagnostic Automation, Inc.
DACD1101-1
In Commercial Distribution

  • 00850049545662 ()

  • 96 tests
1101-1

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

ALBAcyte IgG Sensitized Red Blood Cells II - 05060242472329

These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).
ALBA BIOSCIENCE LIMITED
Z443U
In Commercial Distribution

  • 05060242472336 ()
  • 05060242472329 ()
  • 05060242472343 ()
  • 05060242472350 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control

ALBAcyte IgG Sensitized Red Blood Cells - 05060242471162

ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution

  • 05060242471162 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
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