Identity
- Trade Name
- Pointe Scientific FDA UDI
- Generic Name
- Aspartate aminotransferase (AST) isoenzyme IVD, reagent FDA UDI
- Device Name
- AST reagent for the quantitative determination of Aspartate Aminotransferase (AST) in human serum 6 x 67ml, 6 x 17ml FDA UDI
- Model / Reference
- HA961-504 FDA UDI
- Description
- AST reagent for the quantitative determination of Aspartate Aminotransferase (AST) in human serum 6 x 67ml, 6 x 17ml FDA UDI
Identifiers
- Catalog Number
- HA961-504 FDA UDI
- Primary DI / UDI-DI
- 00811727012890 FDA UDI
- 510(k) Number
- K941132 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
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: Aspartate aminotransferase (AST) isoenzyme IVD, reagent
Pointe Scientific by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aspartate aminotransferase (AST) isoenzyme IVD, reagent.
- AST — Randox Laboratories, Ltd. · Class II
- AST — Randox Laboratories, Ltd. · Class II
- IDG/Sanzay — IDG/SANZAY Corporation · Class II
- SGOT COLORIMETRIC — STERLING DIAGNOSTICS INC
- 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
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 Reagent — POINTE SCIENTIFIC, INC.
- Pointe AST on the BS480 Analyzer — 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 8dc5c2af-e7c4-4c1f-9d3e-ef1bf0400991 37 fields · synced May 30, 2026