FDA UDI
In Commercial Distribution
🇺🇸 United States
IDG/Sanzay
DI: 00850053916038
·
Model: 1
·
IDG/SANZAY Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IDG/Sanzay
- Primary DI
- 00850053916038
- Version / Model
- 1
- Catalog Number
- C065
- Company Name
- IDG/SANZAY Corporation
- Labeler DUNS
- 948875013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-05
- Public Version
- 1
- Public Version Date
- 2024-01-15
- Public Version Status
- New
- Public Device Record Key
- 7755b945-c9b2-4959-8437-d40358a7292a
Device Description
For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reagents are used in routine examination and monitoring of therapy and relapses.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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 |
|---|---|---|---|---|
| 52953 | Aspartate aminotransferase (AST) isoenzyme 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 qualitative and/or quantitative detection of one or multiple aspartate aminotransferase (AST) isoenzymes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850053916038 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981650 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 50 | Milliliter | |
| Total Volume | 100 | Milliliter | |
| Total Volume | 125 | Milliliter | |
| Total Volume | 240 | Milliliter | |
| Total Volume | 1 | Liter | |
| Total Volume | 250 | Milliliter | |
| Total Volume | 500 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius