← Back to catalogue
Liquid Immunoassay Premium - Tri-Level (liq Ia Premium 1, 2 And 3)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3) FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays stated in this package insert. FDA UDI
- Model / Reference
- LIA3108 FDA UDI
- Description
- The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays stated in this package insert. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273207248 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile 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-type clinical chemistry analyte profile IVD, control
Liquid Immunoassay Premium - Tri-Level (liq Ia Premium 1, 2 And 3) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Multiple-type clinical chemistry analyte profile IVD, control.
- Multichem IA — Techno-Path Manufacturing · Class I
- DRUGS OF ABUSE LEVEL 2 — UTAK LABORATORIES, INC. · Class I
- VOLATILES — UTAK LABORATORIES, INC. · Class I
- CCDKM QC LEVEL 2 — UTAK LABORATORIES, INC. · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Immunoassay Control Level 3 — CLINIQA CORPORATION · Class I
- MAS Omni•IMMUNE PRO Max, Sample Pack — Microgenics Corporation · Class I
- DRUGS OF ABUSE LEVEL 1 — UTAK LABORATORIES, 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 1e649f1d-29a3-48de-8f45-993edcd7ea04 35 fields · synced May 31, 2026