FDA.report

HLA-A SSP Kit

Primary DI
07611969953257
Brand
HLA-A SSP Kit
Company
Bio-Rad Medical Diagnostics GmbH
Model
826201
Catalog number
826201
Device description
for 24 determinations of HLA-A alleles; For In Vitro Diagnostic Use
Published
2015-07-01
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
07611969953257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611969953257076119699532577611969953257

GMDN Terms

TermDefinition
HLA class I 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 I antigens in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-224-6723techsupport.bmd@bio-rad.com

Regulatory Flags

DUNS number
312576506
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
false
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 DIBrandModelCatalogPublished
03610520569870IH-Com04.0.270091002017-01-20
03610522055685IH-Card ABO Neutral12008722120087222022-03-09
07611969964505IH-Titration Rack8135501008135501002022-03-09
07611969952205IH-Titration Solution8135601008135601002022-03-03
07611969233786IH-5000015100015102019-07-05
03610522123919IH-Com V5.25.2120102362021-02-18
03610522165049Wash Solution A Concentrate120126682020-02-05
07611969951369Alsevers Solution8065101008065101002015-07-01
07611969965724Alsevers Solution8065101008065101002016-12-26
07611969951352Solidscreen II Negative Control8065091008065091002015-07-01
07611969951468Solidscreen II-Control B8065191008065191002015-07-01
07611969962464Seraclone Anti-k (KEL2)8081261008081261002019-01-15
07611969205486IH-Reader 240012000012002019-01-10
07611969205493IH-10000011000011002017-01-20
07611969234417IH-Com V5.05.0.100091012017-11-09
07611969961719TANGO infinity8500000108500000102016-08-15
07611969069934IH-LISS Rack8135101008135101002017-01-20
07611969950898MLB 28052001008052001002015-07-01
07611969950911MLB 28052051008052051002015-07-01
07611969952182IH-LISS Solution8135201002018-04-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00613745002446GenDx-LongMixGenbioMZI2025-12-27
00613745002453Nuclease-Free WaterGenbioMZI2025-12-27
00613745002491NGSgo-IndX Plate IIIGenbioMZI2025-12-27
00613745002576NGSgo-IndX Plate IIGenbioMZI2025-12-27
00613745002705 NGSgo-IndX Plate I (Indices Illumina)GenbioMZI2025-12-27
00613745003443NGSgo-IndX Illumina Adapter & Indices plate I (96) GenbioMZI2025-12-27
00613745003450NGSgo-IndX Illumina Adapter & Indices plate II (96) GenbioMZI2025-12-27
00613745003474NGSgo-IndX Illumina Adapter & Indices plate IV (96) GenbioMZI2025-12-27
00613745003481GenDx-AMPure XP - AMPure beads and elution buffer (5 ml) GenbioMZI2025-12-27
00613745003689NGS-Turbo® demo workflow reagentsGenbioMZI2025-12-27
00613745003702NGSgo® Pronto demo Workflow reagentsGenbioMZI2025-12-27
00613745003719NGSgo® Pronto demo Wash reagentsGenbioMZI2025-12-27
00613745001630NGSgo Library Full Kit for Illumina IndX Plate IIIGenbioMZI2025-12-26
00613745002293NGSgo Library Full Kit for Illumina IndX Plate IVGenbioMZI2025-12-26
00613745002309 NGSgo-AmpX v2 HLA GeneSuiteGenbioMZI2025-12-26
00613745002316NGSgo Library Full Kit for Illumina IndX Plate IGenbioMZI2025-12-26
00613745002323NGS-TurboAmp Multiplex 11 loci for ONT (12)GenbioMZI2025-12-26
00613745002330NGSgo-MX11-3GenbioMZI2025-12-26
00613745002347NGS-TurboPrep Library preparation for ONT(12)GenbioMZI2025-12-26
00613745002354NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)GenbioMZI2025-12-26
00613745002361NGSgo ProntoPrep HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)GenbioMZI2025-12-26
00613745002378NGSgo Library Full Kit for Illumina IndX plate IIGenbioMZI2025-12-26
00613745002606NGSgo-AmpX v2 HLA-BGenbioMZI2025-12-26
00613745002859AlleleSEQR® HLA-A PCR/Sequencing kit (25)GenbioMZI2025-12-26
00613745002866AlleleSEQR® HLA-B PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002873AlleleSEQR® HLA-C PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002880AlleleSEQR® HLA-DRB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002897AlleleSEQR® HLA-DQB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002903AlleleSEQR® HLA-DPB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002910KMRengine Chimerism monitoring software One year extension GenbioMZI2025-12-26