FDA.reportPublic FDA data

TECO DIAGNOSTICS

Primary DI
10673486000641
Brand
TECO DIAGNOSTICS
Company
TECO DIAGNOSTICS
Model
URS-2K-100GL BOTTLE WITH LABEL
Catalog number
URS-2K-100GL
Device description
TECO DIAGNOSTICS URS-2K-100GL BOTTLE WITH LABEL
Published
2018-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970250000CLINISTRIPTeco Diagnostics1997-04-08JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486000641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600064110673486000641

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick (strip) method. This test is commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
185067774
Device count
1
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
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
00015482104658AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2025-11-07
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIL2024-06-06
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-04
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-04
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
00613647025260FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JIN2023-06-20
40612479183627McKessonMCKESSON MEDICAL-SURGICAL INC.JIL2022-07-28
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIL2022-04-13
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIN2022-04-13
16971404131199Blood Ketone Test Stripse-Linkcare Meditech Co., LtdJIN2021-12-17
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIL2021-09-16
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIN2021-09-16
00021292008178TRUEplusTRIVIDIA HEALTH, INC.JIN2020-10-21
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIN2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIL2020-09-22
10888277110403MedlineMEDLINE INDUSTRIES, INC.JIL2020-08-21
10888277110403MedlineMEDLINE INDUSTRIES, INC.JIN2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJIN2020-07-09