FDA.reportPublic FDA data

FlowPRA™ Single Antigen HLA Class II Antibody Detection Test

Primary DI
00812117011448
Brand
FlowPRA™ Single Antigen HLA Class II Antibody Detection Test
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
FL2HD
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
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812117011448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812117011448008121170114488121170114480812117011448

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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00812117016849uTYPE™ CDx HLA Sequence Analysis SoftwareUTPCDX-PGRUTPCDX-PGR2023-01-30
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00812117015897FluoroQuench Acridine Orange/Ethidium Bromide - 100mlN/AFQAE1002018-05-31
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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
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