FDA.reportPublic FDA data

BioPlex 2200

Primary DI
03610520653012
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
12000650
Catalog number
12000650
Device description
BioPlex 2200 Syphilis Total & RPR Reagent Pack
Published
2017-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GMQANTIGENS, NONTREPONEMAL, ALL
LIPENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMQAntigens, Nontreponemal, AllMicrobiology2
LIPEnzyme Linked Immunoabsorption Assay, Treponema PallidumMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610520653012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610520653012036105206530123610520653012

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum reagin antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
+1(800)224-6723TechSupport.USSD@bio-rad.com

Regulatory Flags#

DUNS number
884513334
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850021758233RPR Carbon AntigenKSL Biomedical, Inc.GMQ2026-04-13
B350GSD011600DIL0GSD RPR DiluentGold Standard Diagnostics CorporationGMQ2025-10-16
15099590763626Access Syphilis ReagentBeckman Coulter, Inc.LIP2025-05-07
B350GSD0116005C0Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5CGold Standard Diagnostics CorporationGMQ2024-12-06
B350GSD051600MW0Microtiterplates (5)Gold Standard Diagnostics CorporationGMQ2024-10-22
10758750035052VITROSORTHO CLINICAL DIAGNOSTICSLIP2024-09-18
20758750035059VITROSORTHO CLINICAL DIAGNOSTICSLIP2024-09-18
00816057021666ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021673ASI RPR Test for Syphilis for Use on the ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021680ASI RPR Test for Syphilis for Use on the ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021697ASI RPR Automated Control Set ARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021703ASI RPR Automated Control Set ARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021710ASI Evolution RPR Titration DiluentARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
B35000400R0AIX1000 AnalyzerGold Standard Diagnostics CorporationGMQ2023-10-31
B350GSD011600DYE0AIX1000 Performance Check Dye KitGold Standard Diagnostics CorporationGMQ2023-09-13
B350GSD051600NC0RPR Non-Reactive ControlGold Standard Diagnostics CorporationGMQ2023-09-13
B350GSD051600PC0RPR Reactive ControlGold Standard Diagnostics CorporationGMQ2023-09-13
03610522183692BioPlexBIO-RAD LABORATORIES, INC.LIP2023-07-28
03610522207992BioPlexBIO-RAD LABORATORIES, INC.LIP2023-07-28
B350GSD051600W0GSD RPR Microtiterplate - 5 pack sleeveGold Standard Diagnostics CorporationGMQ2022-11-25
B350GSD1600WCASE0MicrotiterplatesGold Standard Diagnostics CorporationGMQ2022-10-14
07613336171950Elecsys SyphilisRoche Diagnostics GmbHLIP2022-03-15
07613336171998Elecsys SyphilisRoche Diagnostics GmbHLIP2022-03-15
00894175000077AccuDiag ™ Diagnostic Automation, Inc.GMQ2021-08-11
10673486000689TECO DIAGNOSTICSTECO DIAGNOSTICSGMQ2021-08-11
10673486000696TECO DIAGNOSTICSTECO DIAGNOSTICSGMQ2021-08-11
00607158000083DPP HIV-SyphilisChembio Diagnostic Systems Inc.LIP2020-12-29
00630414599892Atellica IM Syph QCSiemens Healthcare Diagnostics Inc.LIP2020-09-24
00380740138332AlinityAbbott GmbHLIP2020-05-29
05391516746588Bio-StatCLARK LABORATORIES, INC.LIP2019-12-30