Stopping Solution 404585

GUDID 10888234500698

For Use with PakPlus100

IMMUCOR GTI DIAGNOSTICS, INC.

Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
Primary Device ID10888234500698
NIH Device Record Keyf71a8256-e918-4bdb-b498-71e218f49053
Commercial Distribution StatusIn Commercial Distribution
Brand NameStopping Solution
Version Model Number404585
Catalog Number404585
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 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234500698 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-11-03

On-Brand Devices [Stopping Solution]

10888234500698For Use with PakPlus100
10888234500360For Use with PF4 Enhanced (X-HAT13 & X-HAT45), PF4 IgG (HAT13G & HAT45G), LIFECODES B-Screen, LI

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