Identity
- Trade Name
- SP CAL (LIQ) FDA UDI
- Generic Name
- Multiple clinical chemistry protein IVD, calibrator FDA UDI
- Device Name
- Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, RF and Transferrin assays. FDA UDI
- Model / Reference
- IT2691 FDA UDI
- Description
- Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, RF and Transferrin assays. FDA UDI
Identifiers
- Catalog Number
- IT2691 FDA UDI
- Primary DI / UDI-DI
- 05055273204032 FDA UDI
- 510(k) Number
- K061056 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple clinical chemistry protein IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
No
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 clinical chemistry protein IVD, calibrator
Sp Cal (liq) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry protein IVD, calibrator.
- Matrix Plus Cholestereol Reference Kit — VERICHEM LABORATORIES, INC. · Class II
- Total Protein / Albumin Standard Kit — VERICHEM LABORATORIES, INC. · Class II
- Matrix Plus Chemistry Reference, Level F — VERICHEM LABORATORIES, INC. · Class II
- LiniCAL Calibration Verifiers Protein 1 for che Systems Levels A-F — CLINIQA CORPORATION · Class I
- Ammonia / Iron Standard Kit — VERICHEM LABORATORIES, INC. · Class II
- Protein 4 Calibration verifier Set for the Roche Integra — CLINIQA CORPORATION · Class I
- Dimension® Special Protein Calibrator — Siemens Healthcare Diagnostics · Class II
- Total Protein/Albumin Standard Kit, Level F — VERICHEM LABORATORIES, INC. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI f44fa5ce-dfc1-4b3e-a4e9-d61735da7eb7 37 fields · synced May 30, 2026