Anti-Human IgG/A/M Conjugate 404588

GUDID 10888234500575

For Use with PakAuto

IMMUCOR GTI DIAGNOSTICS, INC.

Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
Primary Device ID10888234500575
NIH Device Record Keyd92fcec4-283e-45d6-917d-4e3a7f0e617a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Human IgG/A/M Conjugate
Version Model Number404588
Catalog Number404588
Company DUNS606034197
Company NameIMMUCOR GTI DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-466-8267
Emailwaukeshatechsupport@immucor.co
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com
Phone855-466-8267
Emailwaukeshatechsupport@immucor.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234500575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYPTest,Platelet Antibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-07

On-Brand Devices [Anti-Human IgG/A/M Conjugate]

10888234500582For Use with Pak12 and PakPlus
10888234500575For Use with PakAuto
10888234500391For Use with PF4 Enhanced (X-HAT13 & X-HAT45)

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