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Immunoassay Speciality I - Level 2 (ia Speciality I Lev 2)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMUNOASSAY SPECIALITY I - LEVEL 2 (IA SPECIALITY I LEV 2) 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, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of immunoassays. FDA UDI
- Model / Reference
- IAS3114 FDA UDI
- Description
- This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of immunoassays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273207309 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 Speciality I - Level 2 (ia Speciality I Lev 2) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI b4dc0087-bad6-4d1d-abcc-6dba16372ffb 35 fields · synced May 31, 2026