← Back to catalogue
Immunoassay Premium Plus - Level 1 (ia Premium Plus 1)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMUNOASSAY PREMIUM PLUS - LEVEL 1 (IA PREMIUM PLUS 1) FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert. FDA UDI
- Model / Reference
- IA3109 FDA UDI
- Description
- This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273207255 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
Immunoassay Premium Plus - Level 1 (ia Premium Plus 1) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 940f0d99-b290-4e4e-8e15-1a269d6fbb31 35 fields · synced Jun 1, 2026