FDA.reportPublic FDA data

DRB SSP Kit

Primary DI
07611969953288
Brand
DRB SSP Kit
Company
Bio-Rad Medical Diagnostics GmbH
Model
826215
Catalog number
826215
Device description
Kit for 24 determinations of HLA-DRB alleles; For In Vitro Diagnostic Use
Published
2015-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZITest,Qualitative,For Hla,Non-Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZITest, Qualitative, For Hla, Non-DiagnosticUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611969953288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611969953288076119699532887611969953288

GMDN Terms#

Term, Definition table
TermDefinition
HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple HLA class II antigens in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-224-6723techsupport.bmd@bio-rad.com

Regulatory Flags#

DUNS number
312576506
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07611969233786IH-5000015100015102019-07-05
07611969205493IH-10000011000011002017-01-20
07611969953066Lymphoflot8240128240122015-07-06
07611969953073Lymphostabil8240208240202015-07-06
07611969953080Hanks Solution8240358240352015-07-06
07611969953172Control-HLA (pos.)8241018241012015-07-01
07611969953189Control-HLA (neg.)8241068241062015-07-01
07611969953196Control-HLA-DR (pos.)8241108241102015-07-01
07611969953257HLA-A SSP Kit8262018262012015-07-01
07611969953264HLA-B SSP Kit8262068262062015-07-01
07611969953271HLA-C SSP Kit8262128262122015-07-01
07611969953295DQB SSP Kit8262208262202015-07-01
07611969953301ABDR SSPtray8262308262302015-07-01
07611969953318ABC SSPtray8262408262402015-07-01
07611969965700Lymphoscreen ABC-608233002018-03-08
07611969965717Lymphoscreen DR 30x28233502018-03-08
03610522165049Wash Solution A Concentrate120126682020-02-05
07611969965304Washing Solution Concentrate8480000918480000912016-03-20
03610522136421IH-AbID12010902120109022022-12-13
07611969951369Alsevers Solution8065101008065101002015-07-01

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Primary DI, Brand, Company table
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00382906407764N/ABECTON, DICKINSON AND COMPANYMZI2020-12-17
00382903401833N/ABecton, Dickinson And CompanyMZI2020-12-01
00812117015484PE-Conjugated StreptavidinONE LAMBDA, INC.MZI2020-06-04
00812117010199LABScreen™ Single Antigen HLA Class I ExPlexONE LAMBDA, INC.MZI2020-06-03
00812117014654LABScreen™ Single Antigen HLA Class II ExPlexONE LAMBDA, INC.MZI2020-06-03
10888234500827Dilution SolutionIMMUCOR GTI DIAGNOSTICS, INC.MZI2020-05-20
10888234500803LIFECODES MATCH IT!™ DNA Software v1.3IMMUCOR GTI DIAGNOSTICS, INC.MZI2020-02-26
07611969965700Lymphoscreen ABC-60Bio-Rad Medical Diagnostics GmbHMZI2018-03-08
07611969965717Lymphoscreen DR 30x2Bio-Rad Medical Diagnostics GmbHMZI2018-03-08
10888234400011LIFECODES HLA-A eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
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10888234400066LIFECODES HLA-DRB1 SSO Typing Kit for use with LumineIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
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10888234400080LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
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