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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 - 00845714002786

Stop Solution
IMMCO DIAGNOSTICS, INC.
2316
In Commercial Distribution

  • 00845714002786 ()

  • 12 ml
2316

  • Sulphuric acid stop solution reagent IVD

IMMCO DIAGNOSTICS - 00845714002328

Celiac Fusion (tTG/DGP Ab) ELISA
IMMCO DIAGNOSTICS, INC.
5157
Not in Commercial Distribution

  • 00845714002328 ()

  • 96 Determinations
5157

  • Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTICS - 00845714002229

ACA Screen ELISA
IMMCO DIAGNOSTICS, INC.
5118S
Not in Commercial Distribution

  • 00845714002229 ()

  • 96 DETERMINATIONS
5118S

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTICS - 00845714002212

ACA IgA ELISA
IMMCO DIAGNOSTICS, INC.
5118A
Not in Commercial Distribution

  • 00845714002212 ()

  • 96 DETERMINATIONS
5118A

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTIC - 00845714002199

IgA FITC Conjugate w/ Evans Blue
IMMCO DIAGNOSTICS, INC.
2107
In Commercial Distribution

  • 00845714002199 ()

  • 5 ml
2107

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

IMMCO DIAGNOSTICS - 00845714002175

IgG FITC Conjugate w/ Evans Blue
IMMCO DIAGNOSTICS, INC.
2099
In Commercial Distribution

  • 00845714002175 ()

  • 5 ml
2099

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

IMMCO DIAGNOSTICS - 00845714002090

Anti-Endomysial Antibody (EMA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1114G-PDEX
In Commercial Distribution

  • 00845714002090 ()

  • 48 determinations
1114G-PDEX

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714004247

WASH BUFFER
IMMCO DIAGNOSTICS, INC.
2308-1
In Commercial Distribution

  • 00845714004247 ()

  • for 1 liter
2308-1

  • Buffered wash solution IVD, manual

IMMCO DIAGNOSTICS - 00845714004179

Mounting Medium
IMMCO DIAGNOSTICS, INC.
2506
In Commercial Distribution

  • 00845714004179 ()

  • 60 ML
2506

  • Microscopy mounting medium IVD

IMMCO DIAGNOSTICS - 00845714004162

Mounting Medium
IMMCO DIAGNOSTICS, INC.
2505
In Commercial Distribution

  • 00845714004162 ()

  • 5 ml
2505

  • Microscopy mounting medium IVD
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