Terasaki HLA-C Locus Tissue Typing Tray C72

GUDID 00812117010045

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.

ONE LAMBDA, INC.

HLA class I & II antigen tissue typing IVD, kit, multiplex
Primary Device ID00812117010045
NIH Device Record Keya3140ed8-26b5-4ae2-bb2d-85396de5ee35
Commercial Distribution StatusIn Commercial Distribution
Brand NameTerasaki HLA-C Locus Tissue Typing Tray
Version Model Numbern/a
Catalog NumberC72
Company DUNS118289289
Company NameONE LAMBDA, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.822.8824
Emailtechsupport@onelambda.com
Phone800.822.8824
Emailtechsupport@onelambda.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -65 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812117010045 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-08-11

On-Brand Devices [Terasaki HLA-C Locus Tissue Typing Tray]

00812117010090For use in determining HLA Class I and Class II cell surface antigens with a complement dependen
00812117010045For use in determining HLA Class I and Class II cell surface antigens with a complement dependen

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