FDA.reportPublic FDA data

Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)

Primary DI
10673486013979
Brand
Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)
Company
TECO DIAGNOSTICS
Model
A526-120
Catalog number
A526-120
Device description
Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method) is used for the quantitative determination of alanine aminotransferase (Glutamate pyruvate transaminase, SGPT) in human serum.
Published
2026-01-19
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
CKDHydrazone Colorimetry, Alt/Sgpt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKDHydrazone Colorimetry, Alt/SgptClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883387000ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)Tech-Co, Inc.1988-10-13CKD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486013979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348601397910673486013979

GMDN Terms#

Term, Definition table
TermDefinition
Alanine aminotransferase (ALT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen.

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
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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
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10673486001013Albumin Reagent SetA502-480A502-4802023-07-07
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10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
10673486002461GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-05-14
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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
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTC-ThunderboltTC-Thunderbolt2024-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751483Alanine Aminotransferase Test StripUrit Medical Electronic Co., Ltd.CKD2026-06-01
06935740751490Alanine Aminotransferase Test StripUrit Medical Electronic Co., Ltd.CKD2026-06-01
06935740751506Alanine Aminotransferase Test StripUrit Medical Electronic Co., Ltd.CKD2026-06-01