Identity
- Trade Name
- Lipase NG FDA UDI
- Generic Name
- Lipase IVD, reagent FDA UDI
- Device Name
- The Lipase NG assay is an in vitro diagnostic test used for the determination on AU480 and AU680 automatic analyzers of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only. FDA UDI
- Model / Reference
- B82715 FDA UDI
- Description
- The Lipase NG assay is an in vitro diagnostic test used for the determination on AU480 and AU680 automatic analyzers 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
- B82715 FDA UDI
- Primary DI / UDI-DI
- 08058056681782 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
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
Dimensions & Sizes
- Size
- Total Volume — 150 Milliliter FDA UDI
Category: Lipase IVD, reagent
Lipase NG 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 74041ecf-a0ee-448e-ae33-f3643ec90f0d 37 fields · synced May 30, 2026