← Back to catalogue
LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC) FDA UDI
- Generic Name
- Multiple lipid analyte IVD, control FDA UDI
- Device Name
- Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for HDL, LDL and Triglycerides. FDA UDI
- Model / Reference
- LV10364 FDA UDI
- Description
- Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for HDL, LDL and Triglycerides. FDA UDI
Identifiers
- Catalog Number
- LV10364 FDA UDI
- Primary DI / UDI-DI
- 05055273216455 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Multiple lipid analyte IVD, control
LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Multiple lipid analyte IVD, control.
- Liquichek — Bio-Rad Laboratories · Class I
- LIQUID QC LIPID CONTROL LEVEL — CLINIQA CORPORATION · Class I
- Diazyme — Diazyme Laboratories, Inc.
- LIQUID QC LIPID CONTROL LEVEL 2 — CLINIQA CORPORATION · Class I
- Pointe Scientfic, Inc. Lipid Controls — POINTE SCIENTIFIC, INC. · Class I
- Audit MicroControls Linearity FD Lipids for Roche Systems — Aalto Scientific, Ltd.
- Liquichek — Bio-Rad Laboratories · Class I
- Audit MicroControls Linearity FD Lipids — Aalto Scientific, Ltd.
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 f7dc7e93-da14-4dd6-8412-bb1c5de2ac72 36 fields · synced May 30, 2026