FDA.report

Micro SSP™ AmbiStrips™ HLA Class I - AmB5001

Primary DI
00812117016337
Brand
Micro SSP™ AmbiStrips™ HLA Class I - AmB5001
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
SSPT1-F3
Device description
Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
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
00812117016337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812117016337008121170163378121170163370812117016337

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

Other Devices From This Company

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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

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