Identity
- Trade Name
- IDG/Sanzay FDA UDI
- Generic Name
- Aspartate aminotransferase (AST) isoenzyme IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reagents are used in routine examination and monitoring of therapy and relapses. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- C065 FDA UDI
- Primary DI / UDI-DI
- 00850053916038 FDA UDI
- 510(k) Number
- K981650 FDA UDI
- FDA Product Code
- CIT FDA UDI
- GMDN Term
- Aspartate aminotransferase (AST) isoenzyme IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 50 Milliliter FDA UDITotal Volume — 100 Milliliter FDA UDITotal Volume — 125 Milliliter FDA UDITotal Volume — 240 Milliliter FDA UDITotal Volume — 1 Liter FDA UDITotal Volume — 250 Milliliter FDA UDITotal Volume — 500 Milliliter FDA UDI
Category: Aspartate aminotransferase (AST) isoenzyme IVD, reagent
IDG/Sanzay by IDG/SANZAY Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Aspartate aminotransferase (AST) isoenzyme IVD, reagent.
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- AST — Randox Laboratories, Ltd. · Class II
- AST — Randox Laboratories, Ltd. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® AST RGT. KIT BL-241 — Carolina Liquid Chemistries Corp. · Class II
- AST — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- IDG/SANZAY Corporation
Sources (1)
- FDA UDI 7755b945-c9b2-4959-8437-d40358a7292a 37 fields · synced Jun 1, 2026