Gamma PeG 0705003

GUDID 10888234001782

Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Polyethylene Glycol (PeG) i

IMMUCOR, INC.

Polyethylene glycol (PEG) immunohaematology reagent IVD
Primary Device ID10888234001782
NIH Device Record Key9a3a438a-38ac-4907-957b-8b18584054f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGamma PeG
Version Model Number0705003
Catalog Number0705003
Company DUNS061446282
Company NameIMMUCOR, 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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-466-8267
Emailtech_support@immucor.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234001782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSGMedia, Potentiating For In Vitro Diagnostic Use

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 Date2016-04-15

On-Brand Devices [Gamma PeG]

10888234001799Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group a
10888234001782Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group a

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