FDA.reportPublic FDA data

FlowPRA™ HLA Class I Screening Test - Sample

Primary DI
00812117018157
Brand
FlowPRA™ HLA Class I Screening Test - Sample
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
FL130-SAM
Device description
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
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

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812117018157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812117018157008121170181578121170181570812117018157

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-80 Degrees Celsius-65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812117015484PE-Conjugated StreptavidinN/ALSPSAB22020-06-04
00812117010199LABScreen™ Single Antigen HLA Class I ExPlexN/ALS1AEX012020-06-03
00812117014654LABScreen™ Single Antigen HLA Class II ExPlexN/ALS2AEX012020-06-03
00814695022496UniMatch™ Plus Software N/A7901112016-08-31
00812117015255Adsorb OutN/AADSORB2018-06-15
00814695024452Micro SSP™ Gel System - 108 WellsN/AMGS1082018-06-15
00812117015873Fluorobeads™ T Lymphocyte – 25 Isolations N/AFB1-252018-05-31
00812117015880Fluorobeads™ B Lymphocyte – 25 IsolationsN/AFB2-252018-05-31
00812117015897FluoroQuench Acridine Orange/Ethidium Bromide - 100mlN/AFQAE1002018-05-31
00812117016184FluoroQuench Acridine Orange/Ethidium Bromide - 500mlN/AFQAE5002018-05-31
00812117016207FluoroQuench Acridine Orange/Ethidium Bromide - 2000 mlN/AFQAE20002018-05-31
00812117016832Lympho-Kwik T/B Lymphocyte, 25 isolationsN/ALKTB252018-05-31
00812117018041Fluorobeads™ T Lymphocyte – 100 Isolations N/AFB1-1002018-05-31
00812117018058FluoroBeads™ T Developer (10X)N/AFB1-DEV2018-05-31
00812117018072Fluorobeads™ B Lymphocyte – 100 IsolationsN/AFB2-1002018-05-31
00812117018447FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 mlN/AFQZAE1002018-05-31
00812117018768Lympho-Kwik Mononuclear Cell, 50 isolationsN/ALK-50-MN2018-05-31
00812117018775Lympho-Kwik T Lymphocyte, 50 isolationsN/ALK-50-T2018-05-31
00812117018782Lympho-Kwik T/B Lymphocyte, 50 isolationsN/ALK-50-TB2018-05-31
00812117018799Lympho-Kwik T Lymphocyte, 25 isolationsN/ALKT252018-05-31