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AIX1000 Analyzer

Primary DI
B35000400R0
Brand
AIX1000 Analyzer
Company
Gold Standard Diagnostics Corporation
Model
00400R
Catalog number
00400R
Device description
AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished)
Published
2023-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GMQAntigens, Nontreponemal, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMQAntigens, Nontreponemal, AllMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150358000
K250249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150358000Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics2015-11-12GMQ
K250249000Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC2025-10-10GMQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B35000400R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum reagin antibody IVD, kit, agglutinationA collection of reagents and other associated materials intended to be 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 using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790524891
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3507207900Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit720-790720-7902025-02-26
B350GSD0113000Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test KitGSD01-13002016-09-27
B350GSD0116005C0Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5CGSD01-1600-5CGSD01-1600-5C2024-12-06
B350GSD051600MW0Microtiterplates (5)GSD05-1600-MWGSD05-1600-MW2024-10-22
B350GSD011600DYE0AIX1000 Performance Check Dye KitGSD01-1600-DYEGSD01-1600-DYE2023-09-13
B350GSD051600NC0RPR Non-Reactive ControlGSD05-1600-NCGSD05-1600-NC2023-09-13
B350GSD051600PC0RPR Reactive ControlGSD05-1600-PCGSD05-1600-PC2023-09-13
B350GSD1600WCASE0MicrotiterplatesGSD-1600-W-CASEGSD-1600-W-CASE2022-10-14
B350004000AIX1000 Analyzer004002016-11-29
B350GSD0116000Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test SystemGSD01-16002016-09-27
B350GSD341600R0Gold Standard Diagnostics RPR Reagent PackGSD34-1600-RGSD34-1600-R2016-11-29
B350GSD011600DIL0GSD RPR DiluentGSD01-1600-DILGSD01-1600-DIL2025-10-16
B350GSD0110010Gold Standard Diagnostics H. pylori ELISA IgA Test KitGSD01-10012016-09-27
B350GSD051600W0GSD RPR Microtiterplate - 5 pack sleeveGSD05-1600-WGSD05-1600-W2022-11-25
B350GSD011029CP0SARS-CoV-2 Component PackGSD01-1029-CPGSD01-1029-CP2022-10-07
B350GSD011029SP0SARS-CoV-2 IgA Sera PackGSD01-1029-SPGSD01-1029-SP2022-10-07
B350GSD011002RP0IgM Reagent PackGSD01-1002-RPGSD01-1002-RP2022-10-28
B350GSD011002CP0H. pylori IgM Sera PackGSD01-1002-CPGSD01-1002-CP2022-10-07
B350GSD011002HCP0H. pylori Component PackGSD01-1002-HCPGSD01-1002-HCP2022-10-07
B350GSD0124500Performance Check Dye KitGSD01-2450GSD01-24502023-09-13

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
B350GSD0116005C0Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5CGold Standard Diagnostics CorporationGMQ2024-12-06
B350GSD051600MW0Microtiterplates (5)Gold Standard Diagnostics CorporationGMQ2024-10-22
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
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
B350GSD051600W0GSD RPR Microtiterplate - 5 pack sleeveGold Standard Diagnostics CorporationGMQ2022-11-25
B350GSD1600WCASE0MicrotiterplatesGold Standard Diagnostics CorporationGMQ2022-10-14
00894175000077AccuDiag ™ Diagnostic Automation, Inc.GMQ2021-08-11
10673486000689TECO DIAGNOSTICSTECO DIAGNOSTICSGMQ2021-08-11
10673486000696TECO DIAGNOSTICSTECO DIAGNOSTICSGMQ2021-08-11
03610522004980BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2018-02-05
03610522015597BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2018-02-05
03610520138267BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
03610520992692BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
03610520653012BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
10722355001767Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001774Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001781Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001798Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001804Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001811Detector RPRImmunostics Company, IncGMQ2016-12-03
B350004000AIX1000 AnalyzerGold Standard Diagnostics CorporationGMQ2016-11-29