Identity
- Trade Name
- LIPASE (LPS) FDA UDI
- Generic Name
- Lipase IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- LI8050 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273209136 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
Yes
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
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, kit, spectrophotometry
Lipase (lps) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lipase IVD, kit, spectrophotometry.
- Dimension® Flex® reagent cartridge LIPL — Siemens Healthcare Diagnostics · Class I
- LIPASE Color — Sekisui Diagnostics, LLC · Class I
- Lipase — POINTE SCIENTIFIC, INC. · Class I
- ADVIA® Chemistry LIP Lipase Reagents — Siemens Healthcare Diagnostics · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT ST621 — Carolina Liquid Chemistries Corp. · Class I
- Dimension Lipase (LIP) Flex reagent cartridge — Siemens Healthcare Diagnostics · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT CC621 — Carolina Liquid Chemistries Corp. · Class I
- Pointe Scientific, Inc. Lipase-Color — POINTE SCIENTIFIC, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI ff184ef5-2fae-4a43-b3bb-33e39b0893f7 32 fields · synced Jun 8, 2026