FDA.reportPublic FDA data

Microtiterplates (5)

Primary DI
B350GSD051600MW0
Brand
Microtiterplates (5)
Company
Gold Standard Diagnostics Corporation
Model
GSD05-1600-MW
Catalog number
GSD05-1600-MW
Device description
Microtiterplates (5)
Published
2024-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
B350GSD051600MW0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Assay container IVD, single-useA reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790524891
Device count
1
Lot or batch
true
Expiration date on label
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
B35000400R0AIX1000 Analyzer00400R00400R2023-10-31
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
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
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