FDA.reportPublic FDA data

Lymphoscreen ABC-60

Primary DI
07611969952939
Brand
Lymphoscreen ABC-60
Company
Bio-Rad Medical Diagnostics GmbH
Model
823300
Catalog number
823300
Device description
Human lymphocytes for 6 detections of human HLA-ABC antibodies 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
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
BK9800330

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9800330

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611969952939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611969952939076119699529397611969952939

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)A collection of reagents and other associated materials intended to be used for the identification in a clinical specimen of one or multiple antibodies to HLA class I antigens, using lymphocyte antigens together with a complement-dependent cytotoxicity (CDC) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-70 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613745003948ONtrack AmpGenBioMZI2026-06-08
00613745003955ONtrack PrepGenBioMZI2026-06-08
00613745003962HISTO SPOT ® HLA AB Reagent KitGenBioMZI2026-06-08
00613745003979HISTO SPOT ® HLA AB ID CLASS II – AD1GenBioMZI2026-06-08
00613745003986HISTO SPOT ® HLA AB ID CLASS IIGenBioMZI2026-06-08
00613745003993HISTO SPOT ® HLA AB ID CLASS IGenBioMZI2026-06-08
00613745003931NGSgo-AmpX v3 HLA-DRB3/4/5 (96)GenBioMZI2026-05-15
00613745003870NGSgo®-AmpX v2 EnhancerGenBioMZI2026-05-06
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