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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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IMMCO DIAGNOSTICS - 00845714003714

Pemphigold Positive
IMMCO DIAGNOSTICS, INC.
2217
In Commercial Distribution

  • 00845714003714 ()

  • .5 ml
2217

  • Skin antibody IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714003677

nDNA Positive Control
IMMCO DIAGNOSTICS, INC.
2215
In Commercial Distribution

  • 00845714003677 ()

  • .5 ml
2215

  • Double stranded DNA antibody (anti-dsDNA) IVD, reagent

IMMCO DIAGNOSTICS - 00845714003660

Pemphigus Vulgaris Positive Control
IMMCO DIAGNOSTICS, INC.
2214
In Commercial Distribution

  • 00845714003660 ()

  • .5 ml
2214

  • Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTICS - 00845714003479

IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2100X
In Commercial Distribution

  • 00845714003479 ()

  • 5 ml
2100X

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

IMMCO DIAGNOSTICS - 00845714003318

Negative Control
IMMCO DIAGNOSTICS, INC.
2200
In Commercial Distribution

  • 00845714003318 ()

  • .5 ml
2200

  • Immunohistochemistry negative control (normal animal serum) IVD

IMMCO DIAGNOSTICS - 00845714003257

Intercellular Positive
IMMCO DIAGNOSTICS, INC.
2213
In Commercial Distribution

  • 00845714003257 ()

  • .5 ml
2213

  • Skin antibody IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714003059

IgA/IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2113X
In Commercial Distribution

  • 00845714003059 ()

  • 5 ml
2113X

  • Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD

IMMCO DIAGNOSTICS - 00845714003035

IgA FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2107X
In Commercial Distribution

  • 00845714003035 ()

  • 5 ml
2107X

  • Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

IMMCO DIAGNOSTICS - 00845714002991

IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2099X
In Commercial Distribution

  • 00845714002991 ()

  • 5 ml
2099X

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

IMMCO DIAGNOSTICS - 00845714002861

AMA Positive Control
IMMCO DIAGNOSTICS, INC.
2210
In Commercial Distribution

  • 00845714002861 ()

  • .5 ml
2210

  • Mitochondrial antibody M2 (anti-Mi2) IVD, reagent
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