LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use wit 628927

GUDID 10888234400080

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching

IMMUCOR GTI DIAGNOSTICS, INC.

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)
Primary Device ID10888234400080
NIH Device Record Keyc7241054-5280-4bbd-9163-43ffcb9a26ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use wit
Version Model Number628927
Catalog Number628927
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 Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Light

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234400080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZITest,Qualitative,For Hla,Non-Diagnostic

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 Date2016-09-15

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