corQC EXTEND Complete 0066297

GUDID 10888234001331

corQC EXTEND Complete is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents.

IMMUCOR, INC.

Multiple immunohaematology test IVD, control
Primary Device ID10888234001331
NIH Device Record Keyd1756678-1370-4724-9fdc-59f31c31c497
Commercial Distribution StatusIn Commercial Distribution
Brand NamecorQC EXTEND Complete
Version Model Number0066297
Catalog Number0066297
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
GS110888234001331 [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 Date2016-04-14

Devices Manufactured by IMMUCOR, INC.

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10888234002314 - Capture-P Indicator Red Cells2022-09-12 Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the dete
10888234001522 - Referencells2022-08-11 Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.

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