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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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JAS Diagnostics - 00817274021774

HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
XL-A1C2-30
In Commercial Distribution

  • 00817274021774 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

JAS Diagnostics - 00817274021767

HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
A1C2-30
In Commercial Distribution

  • 00817274021767 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

JAS Diagnostics - 00817274021750

HEMOGLOBIN A1C REAGENT (1x 30mL R1, 1x 9.5mL R2a, 1x 0.5mL R2b
DREW SCIENTIFIC, INC.
A1C2-30A
In Commercial Distribution

  • 00817274021750 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

NovaLisa Entamoeba histolytica IgG - ENTIENTG01400

The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
ENTG0140
In Commercial Distribution

  • ENTIENTG01400 ()
ENTG0140

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Serodia TP-PA - 00850212007027

220 test kit
FUJIREBIO DIAGNOSTICS, INC.
1633
In Commercial Distribution

  • 00850212007027 ()

  • Size Type = Tests per Kit; Size Unit = 220; Unit of Measure = Tests


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

Serodia TP-PA - 00850212007010

100 test kit
FUJIREBIO DIAGNOSTICS, INC.
1626
In Commercial Distribution

  • 00850212007010 ()

  • Size Type = Tests per Kit; Size Unit = 100; Unit of Measure = Tests


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

PK7400 TP HA REAGENT - 05060515140030

PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.
NEWMARKET BIOMEDICAL LIMITED
B11186
In Commercial Distribution

  • 05060515140030 ()

  • 3600 tests


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

Serodia TP-PA Kits - 00869164000062

220 test kits
FUJIREBIO DIAGNOSTICS, INC.
234976
In Commercial Distribution

  • 00869164000062 ()

  • 220 tests per kit


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

Serodia TP-PA Kits - 00869164000055

100 test kit
FUJIREBIO DIAGNOSTICS, INC.
234952
In Commercial Distribution

  • 00869164000055 ()

  • 100 tests per kit


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

Beckman Coulter PK TP System - 04987270226964

No Description
FUJIREBIO INC.
226964
In Commercial Distribution

  • 04987270226964 ()

  • Size Type = Tests Per Kit; Size Unit = 3000; Unit of Measure = Tests
PH3000

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