DAT Positive Control Cell 0066125

GUDID 10888234001119

DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cell

IMMUCOR, INC.

Multiple immunohaematology test IVD, control
Primary Device ID10888234001119
NIH Device Record Key5198efca-e34f-4fc1-8f63-870a1926e053
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAT Positive Control Cell
Version Model Number0066125
Catalog Number0066125
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
GS110888234001119 [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 Date2016-04-15

On-Brand Devices [DAT Positive Control Cell]

10888234001119DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DA
10888234001102DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DA

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