FDA.reportPublic FDA data

TECO DIAGNOSTICS

Primary DI
10673486000993
Brand
TECO DIAGNOSTICS
Company
TECO DIAGNOSTICS
Model
D770-25
Catalog number
D770-25
Device description
Alcohol Dipstick Test Kit (25 Tests)
Published
2022-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111206000TECO DIAGNOSTICS SALIVA ALCOHOL TESTTeco Diagnostics2011-10-04DIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486000993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600099310673486000993

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, colorimetric, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a colorimetric method. This test is commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
00630414654089Atellica CH Ethanol (EtohC)Siemens Healthcare Diagnostics Inc.DIC2025-10-15
00816862024531WondfoWONDFO USA CO., LTD.DIC2024-05-23
10816862024538WondfoWONDFO USA CO., LTD.DIC2024-05-23
06970429841444co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841536co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841628co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841703co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841802co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841901co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
00816862022995WondfoWONDFO USA CO., LTD.DIC2021-08-20
00816862023015WondfoWONDFO USA CO., LTD.DIC2021-08-20
10816862022992WondfoWONDFO USA CO., LTD.DIC2021-08-20
10816862023012WondfoWONDFO USA CO., LTD.DIC2021-08-20
06970429841611co-innovationCo-Innovation Biotech Co., LtdDIC2021-03-29
00811727017390Pointe Ethyl Alcohol Reagent SetHORIBA INSTRUMENTS INCORPORATEDDIC2020-09-25
00811727017406Pointe Ethyl Alcohol Reagent SetHORIBA INSTRUMENTS INCORPORATEDDIC2020-09-25
07613336121221Ethanol Gen.2Roche Diagnostics GmbHDIC2020-03-05
07613336157817Ethanol Gen.2Roche Diagnostics GmbHDIC2020-03-05
00816862022339WondfoWONDFO USA CO., LTD.DIC2020-02-20
10816862022336WondfoWONDFO USA CO., LTD.DIC2020-02-20
B2984090010AlcoCheckExpress Diagnostic Int'l, Inc.DIC2019-05-02
06970429841284co-innovationCo-Innovation Biotech Co., LtdDIC2019-03-22
26970429841288co-innovationCo-Innovation Biotech Co., LtdDIC2019-03-22
00628063401086Ethanol AssaySEKISUI DIAGNOSTICS, LLCDIC2018-11-28
00840937110355ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110362ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110379ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110386ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00817830022825MP Saliva Alcohol Test StripRAPID DIAGNOSTICS INCDIC2017-08-03
B298409000AlcoCheckEXPRESS DIAGNOSTICS INT'L, INC.DIC2017-02-20