FDA.report

AllSet+™ Gold SSP DRB1*13 High Resolution Kit

Primary DI
00814695022366
Brand
AllSet+™ Gold SSP DRB1*13 High Resolution Kit
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
54270D
Device description
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
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
00814695022366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814695022366008146950223668146950223660814695022366

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-30 Degrees Celsius8 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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00812117016207FluoroQuench Acridine Orange/Ethidium Bromide - 2000 mlN/AFQAE20002018-05-31
00812117016832Lympho-Kwik T/B Lymphocyte, 25 isolationsN/ALKTB252018-05-31
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00812117018058FluoroBeads™ T Developer (10X)N/AFB1-DEV2018-05-31
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00812117018799Lympho-Kwik T Lymphocyte, 25 isolationsN/ALKT252018-05-31

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