FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)
DI: 10673486013979
·
Model: A526-120
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)
- Primary DI
- 10673486013979
- Version / Model
- A526-120
- Catalog Number
- A526-120
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-19
- Public Version
- 1
- Public Version Date
- 2026-01-27
- Public Version Status
- New
- Public Device Record Key
- 38fe2a04-f8f6-453f-8b04-a4ef0f6becfe
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CKD | Hydrazone Colorimetry, Alt/Sgpt | Clinical Chemistry | 862.1030 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52925 | Alanine aminotransferase (ALT) IVD, reagent | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486013979 | GS1 |
Customer Contacts
- Phone
- 7144631111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K883387 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius