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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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Cyclone Platelet Rich Plasma (PRP) Concentrating System - M686CYCP60020

No Description
ALLIANCE PARTNERS LLC
CYCP-60-02
In Commercial Distribution

  • M686CYCP60020 ()
CYCP-60-02

  • Haematological concentrate system

Cyclone Concentrating System - M686CYC60020

No Description
ALLIANCE PARTNERS LLC
CYC-60-02
In Commercial Distribution

  • M686CYC60020 ()
CYC-60-02

  • Haematological concentrate system

Cyclone Concentrating System - M686CYC120020

No Description
ALLIANCE PARTNERS LLC
CYC-120-02
In Commercial Distribution

  • M686CYC120020 ()
CYC-120-02

  • Haematological concentrate system

Dilution Solution - 10888234500827

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515UDI
In Commercial Distribution

  • 10888234500827 ()
628515UDI

  • Buffered sample diluent IVD

LIFECODES MATCH IT!™ DNA Software v1.3 - 10888234500803

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888623
In Commercial Distribution

  • 10888234500803 ()
888623

  • Laboratory instrument/analyser application software IVD

PakAuto® - 10888234500728

PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKAUTO-MAYO
Not in Commercial Distribution

  • 10888234500728 ()
PAKAUTO-MAYO

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)

PakPlus® - 10888234500674

The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/II.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS100
Not in Commercial Distribution

  • 10888234500674 ()
PAKPLUS100

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

PNPP Substrate - 10888234500650

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
403594
Not in Commercial Distribution

  • 10888234500650 ()
403594

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500643

For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404601
Not in Commercial Distribution

  • 10888234500643 ()
404601

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500636

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404600
Not in Commercial Distribution

  • 10888234500636 ()
404600

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
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