Identity
- Trade Name
- Lipase Color Liquid FDA UDI
- Generic Name
- Lipase IVD, kit, spectrophotometry FDA UDI
- Device Name
- The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. FDA UDI
- Model / Reference
- 17401B FDA UDI
- Description
- The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. FDA UDI
Identifiers
- Catalog Number
- 17401B FDA UDI
- Primary DI / UDI-DI
- 08058056680617 FDA UDI
- 510(k) Number
- K961179 FDA UDI
- FDA Product Code
- CHI FDA UDI
- GMDN Term
- Lipase IVD, kit, spectrophotometry 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
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
Dimensions & Sizes
- Size
- Total Volume — 49 Milliliter FDA UDI
Category: Lipase IVD, kit, spectrophotometry
Lipase Color Liquid by Sentinel Ch. Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sentinel Ch. Srl
Sources (1)
- FDA UDI e952378d-9a0d-4725-8813-bb4bb4350579 38 fields · synced May 30, 2026