Identity
- Trade Name
- VITROS FDA UDI
- Generic Name
- Homocysteine IVD, calibrator FDA UDI
- Device Name
- VITROS Chemistry Products HCY 2 Performance Verifier I, II, III FDA UDI
- Model / Reference
- 6842957 FDA UDI
- Description
- VITROS Chemistry Products HCY 2 Performance Verifier I, II, III FDA UDI
Identifiers
- Catalog Number
- 6842957 FDA UDI
- Primary DI / UDI-DI
- 10758750030163 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Homocysteine IVD, calibrator 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
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
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: Homocysteine IVD, calibrator
Vitros by Ortho-Clinical Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Homocysteine IVD, calibrator.
- Alinity — Abbott · Class II
- ARCHITECT — Abbott · Class II
- Homocysteine Calibrator Kit — Roche Diagnostics Corp. · Class II
- ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator — Siemens Healthcare Diagnostics · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
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
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 417d22fe-7e91-4b0b-8fc0-314437b3e398 35 fields · synced May 30, 2026