Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Lipase IVD, reagent FDA UDI
- Device Name
- Lipase Reagent FDA UDI
- Model / Reference
- SA1045 FDA UDI
- Description
- Lipase Reagent FDA UDI
Identifiers
- Catalog Number
- SA1045 FDA UDI
- Primary DI / UDI-DI
- 00857969006549 FDA UDI
- 510(k) Number
- K113438 FDA UDI
- FDA Product Code
- CHI FDA UDI
- GMDN Term
- Lipase IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1465 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
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: Lipase IVD, reagent
Ace by Alfa Wassermann, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Lipase NG — Sentinel Ch. Srl · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
Cleared under the same submission
K113438 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Alfa Wassermann, Inc.
Sources (1)
- FDA UDI c1d9dc56-ba51-4134-878b-70d2d91593ce 37 fields · synced May 30, 2026