FDA UDI
In Commercial Distribution
🇺🇸 United States
AST (SGOT) KINETIC METHOD TC MATRIX-240/480
DI: 10673486001167
·
Model: A559-780
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AST (SGOT) KINETIC METHOD TC MATRIX-240/480
- Primary DI
- 10673486001167
- Version / Model
- A559-780
- Catalog Number
- A559-780
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-20
- Public Version
- 1
- Public Version Date
- 2023-07-28
- Public Version Status
- New
- Public Device Record Key
- cb46b345-fdfb-435b-9ec7-6741e79fa0ad
Device Description
The AST (SGOT) KINETIC METHOD TC MATRIX-240/480 is used for the quantitative determination of aspartate aminotransferase activity in serum or plasma on TC Matrix analyzer.
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 |
|---|---|---|---|---|
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | Clinical Chemistry | 862.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52955 | Total aspartate aminotransferase (AST) 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 total aspartate aminotransferase (AST) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486001167 | GS1 |
Customer Contacts
- Phone
- 714-463-1111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981650 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius