LABType™ XR Class I C Locus Typing Test - Sample RSSOX1CS

GUDID 00814695024322

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

HLA class I & II antigen tissue typing IVD, kit, multiplex HLA class I & II antigen tissue typing IVD, kit, multiplex
Primary Device ID00814695024322
NIH Device Record Key0bbf80b7-9dc2-428a-b2b7-5f10ffab74b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLABType™ XR Class I C Locus Typing Test - Sample
Version Model NumberN/A
Catalog NumberRSSOX1CS
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 -80 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814695024322 [Primary]

FDA Product Code

MZITest,Qualitative,For Hla,Non-Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-16
Device Publish Date2018-03-16

On-Brand Devices [LABType™ XR Class I C Locus Typing Test - Sample]

00814695024346HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matchi
00814695024322HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matchi

Trademark Results [LABType]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LABTYPE
LABTYPE
76372187 2695208 Live/Registered
ONE LAMBDA, INC.
2002-02-20

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