FDA.reportPublic FDA data

DQB SSP Kit

Primary DI
07611969953295
Brand
DQB SSP Kit
Company
Bio-Rad Medical Diagnostics GmbH
Model
826220
Catalog number
826220
Device description
Kit for 24 determinations of HLA-DQB 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0200040

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0200040

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611969953295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611969953295076119699532957611969953295

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
07611969953288DRB SSP Kit8262158262152015-07-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00613745003887NGSgo®-LibrX End Prep EnzymeGenBioMZI2026-05-06
00613745003894NGSgo®-LibrX End Prep BufferGenBioMZI2026-05-06
00613745003900NGSgo®-LibrX Ligase MixGenBioMZI2026-05-06
00613745003917NGSgo®-LibrX Ligation EnhancerGenBioMZI2026-05-06
00613745003924GenDx-LongMixGenBioMZI2026-05-06
00613745003863NGSgo®-AmpX v2GenBioMZI2026-03-30
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