Identity
- Trade Name
- Lipase NG OC Cal FDA UDI
- Generic Name
- Lipase IVD, calibrator FDA UDI
- Device Name
- Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use. FDA UDI
- Model / Reference
- 04Y85-01 FDA UDI
- Description
- Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 04Y85-01 FDA UDI
- Primary DI / UDI-DI
- 08058056682291 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Lipase IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
Yes
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, calibrator
Lipase NG OC Cal by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lipase IVD, calibrator.
- Diazyme — Diazyme Laboratories, Inc.
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- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Dimension/Vista Lipase Calibrator — Siemens Healthcare Diagnostics · Class II
- Pointe Scientific, Inc. Lipase Standard — POINTE SCIENTIFIC, INC. · Class I
- Lipase NG Cal — Sentinel Ch. Srl · Class II
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
- Sentinel Ch. Srl
Sources (1)
- FDA UDI bc01996a-853c-484c-8e7a-dfb4c70e7900 36 fields · synced May 30, 2026