Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
- Device Name
- Consolidated Chemistry Calibrator FDA UDI
- Model / Reference
- 04V6201 FDA UDI
- Description
- Consolidated Chemistry Calibrator FDA UDI
Identifiers
- Catalog Number
- 04V6201 FDA UDI
- Primary DI / UDI-DI
- 00380740164980 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile 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
No
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, calibrator
Alinity by Abbott Ireland — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type clinical chemistry analyte profile IVD, calibrator.
- VITROS — Ortho-Clinical Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910 — Carolina Liquid Chemistries Corp. · Class II
- no MS ISE Calibrator Direct) — Roche Diagnostics Corp. · Class II
- Dimension Vista CHEM 1 CAL — Siemens Healthcare Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 3 CC910 — Carolina Liquid Chemistries Corp. · Class II
- ADVIA® Chemistry ToxAmmonia Cal — Siemens Healthcare Diagnostics · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Alfa Wassermann — Alfa Wassermann, 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
- Abbott Ireland
Sources (1)
- FDA UDI dfdb2cbd-4b81-421e-ba83-f9d808db9d7f 36 fields · synced Jun 8, 2026