FDA.reportPublic FDA data

Lymphotype HLA-ABC 72

Primary DI
07611969952717
Brand
Lymphotype HLA-ABC 72
Company
Bio-Rad Medical Diagnostics GmbH
Model
823020
Catalog number
823020
Device description
for 6 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
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
OTC
false
Sterile
false
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
07611969952717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611969952717076119699527177611969952717

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)A 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 antigens in a clinical specimen, using a complement-dependent cytotoxicity (CDC) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-20 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
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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

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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
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00613745002316NGSgo Library Full Kit for Illumina IndX Plate IGenbioMZI2025-12-26
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