Identity
- Trade Name
- Pointe AST Reagent FDA UDI
- Generic Name
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe AST Reagent packaged for use on the Mindray BA800. 5 x 67ml R1, 5 x 17ml R2. For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. FDA UDI
- Model / Reference
- 16-A7561-420 FDA UDI
- Description
- Pointe AST Reagent packaged for use on the Mindray BA800. 5 x 67ml R1, 5 x 17ml R2. For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. FDA UDI
Identifiers
- Catalog Number
- 16-A7561-420 FDA UDI
- Primary DI / UDI-DI
- 00811727016041 FDA UDI
- 510(k) Number
- K941132 FDA UDI
- FDA Product Code
- CIT FDA UDI
- GMDN Term
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Pointe AST Reagent by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K941132 also covers:
- POINTE SCIENTIFIC AST — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC AST (SGOT) Liquid — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC AST (SGOT) Liquid — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC AST (SGOT) Liquid — POINTE SCIENTIFIC, INC.
- Pointe AST on the BS480 Analyzer — POINTE SCIENTIFIC, INC.
- Pointe Scientific — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. AST — POINTE SCIENTIFIC, INC.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 9cc0b097-f905-4df7-9d8f-aa1c0897e34b 37 fields · synced May 31, 2026