Negative Serum Control 404573

GUDID 10888234500513

For Use with Pak12G

IMMUCOR GTI DIAGNOSTICS, INC.

Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
Primary Device ID10888234500513
NIH Device Record Keyf67d1174-4a3e-48e0-90d7-2d4361b54a13
Commercial Distribution Discontinuation2017-09-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNegative Serum Control
Version Model Number404573
Catalog Number404573
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
GS110888234500513 [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 Date2016-07-08

On-Brand Devices [Negative Serum Control]

10888234500544For Use with PakPlus
10888234500537For Use with PakAuto
10888234500520For Use with Pak2-LE
10888234500513For Use with Pak12G
10888234500506For Use with Pak12
10888234500414For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)

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