Gamma-clone Control 0420410

GUDID 10888234001751

Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This produc

IMMUCOR, INC.

Multiple immunohaematology test IVD, control
Primary Device ID10888234001751
NIH Device Record Keyd45aaafe-0822-4172-ab81-5dd28fb2d9da
Commercial Distribution StatusIn Commercial Distribution
Brand NameGamma-clone Control
Version Model Number0420410
Catalog Number0420410
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
GS110888234001751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSFKit, Quality Control For Blood Banking Reagents

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 Date2016-04-18

On-Brand Devices [Gamma-clone Control]

10888234001751Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents
10888234001744Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents

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