FDA.report

Lambda Cell Tray™ 72 T Cell Panel

Primary DI
00812117015170
Brand
Lambda Cell Tray™ 72 T Cell Panel
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
LCT1W72
Device description
Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
Published
2016-08-11
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
00812117015170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812117015170008121170151708121170151700812117015170

GMDN Terms

TermDefinition
HLA class I & II antibody screening IVD, kit, multiplexA collection of reagents and other associated materials intended to be used in screening for one or multiple antibodies to HLA class I and II antigens in a clinical specimen, using solid phase antigens together with a multiplex method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-65 Degrees Celsius0 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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00812117015897FluoroQuench Acridine Orange/Ethidium Bromide - 100mlN/AFQAE1002018-05-31
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