Positive Serum Control 404600

GUDID 10888234500636

For Use with PakAuto

IMMUCOR GTI DIAGNOSTICS, INC.

Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
Primary Device ID10888234500636
NIH Device Record Key8342788e-8f19-4a7d-9f39-8a4e8c821a7a
Commercial Distribution Discontinuation2018-08-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePositive Serum Control
Version Model Number404600
Catalog Number404600
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234500636 [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 Number4
Public Version Date2018-08-01
Device Publish Date2016-07-07

On-Brand Devices [Positive Serum Control]

10888234500643For Use with PakPlus
10888234500636For Use with PakAuto
10888234500629For Use with Pak2-LE
10888234500612For Use with Pak12G
10888234500605For Use with Pak12
10888234500438For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)

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