FDA.reportPublic FDA data

TECO DIAGNOSTICS

Primary DI
10673486000689
Brand
TECO DIAGNOSTICS
Company
TECO DIAGNOSTICS
Model
RPR-100
Catalog number
RPR-100
Device description
RPR, 1x100 Tests
Published
2021-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K864731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864731000OCEAN SCIENTIFIC VDRL TESTOcean Scientific, Inc.1987-03-10GMQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486000689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600068910673486000689

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.

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
7144631111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10673486014068Teco Diagnostics Infectious Mononucleosis (IM) Latex TestIML-50IML-502026-05-21
10673486014051Teco Diagnostics Anti-Streptolysin O (ASO) Reagent SetASO-50ASO-502026-05-07
10673486014037Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240C514-650TC2C514-650TC22026-04-30
10673486014044Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480C514-650TC4C514-650TC42026-04-30
10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestP597-25P597-252026-04-09
10673486014013Teco Diagnostics Chemistry CalibratorTC-CAL-MULTITC-CAL-MULTI2026-03-20
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick TestP595-AP595-A2026-02-12
10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestF735-25F735-252026-01-30
10673486013986Teco Diagnostics H. Pylori Card TestH730-50H730-502026-01-27
10673486013979Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)A526-120A526-1202026-01-19
10673486001013Albumin Reagent SetA502-480A502-4802023-07-07
10673486001020Albumin -BCG method TC-MatrixA502-510TMA502-510TM2023-07-07
10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
10673486002461GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-05-14
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MATRIX-160TC-MATRIX-1602025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-240TC-Matrix-2402025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-480TC-Matrix-4802025-05-28
10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestP596-25P596-252024-12-19

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
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
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