Identity
- Trade Name
- VITROS FDA UDI
- Generic Name
- C-peptide IVD, calibrator FDA UDI
- Device Name
- VITROS Immunodiagnostic Products C-peptide Calibrators FDA UDI
- Model / Reference
- 6844424 FDA UDI
- Description
- VITROS Immunodiagnostic Products C-peptide Calibrators FDA UDI
Identifiers
- Catalog Number
- 6844424 FDA UDI
- Primary DI / UDI-DI
- 10758750032051 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- C-peptide 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
Yes
FDA UDI
Category: C-peptide IVD, calibrator
Vitros by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-peptide IVD, calibrator.
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- ADVIA Centaur® Systems, ACS:180® Systems CpS Calibrator — Siemens Healthcare Diagnostics · Class II
- Atellica IM CpS Calibrator — Siemens Healthcare Diagnostics · 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 |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI ab3be0ff-7a23-4fdc-b7cf-de1fcc9f7af5 35 fields · synced Jun 1, 2026