FDA.report

LABType™ CWD Class I C Locus Typing Test

Primary DI
00814695022656
Brand
LABType™ CWD Class I C Locus Typing Test
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
RSSOW1C
Device description
HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
Published
2018-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MZITest,Qualitative,For Hla,Non-Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
MZITest, Qualitative, For Hla, Non-DiagnosticUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814695022656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814695022656008146950226568146950226560814695022656

GMDN Terms

TermDefinition
HLA class I & II antigen tissue typing IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-80 Degrees Celsius-20 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800.822.8824techsupport@onelambda.com

Regulatory Flags

DUNS number
118289289
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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