Identity
- Trade Name
- VITROS FDA UDI
- Generic Name
- Buffered sample diluent IVD, manual FDA UDI
- Device Name
- VITROS Chemistry Products Specialty Diluent FDA UDI
- Model / Reference
- 8559825 FDA UDI
- Description
- VITROS Chemistry Products Specialty Diluent FDA UDI
Identifiers
- Catalog Number
- 8559825 FDA UDI
- Primary DI / UDI-DI
- 10758750005024 FDA UDI
- FDA Product Code
- GIF FDA UDI
- GMDN Term
- Buffered sample diluent IVD, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8200 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
No
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: Buffered sample diluent IVD, manual
Vitros by Ortho-Clinical Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered sample diluent IVD, manual.
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class I
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- Trinity Biotech — CLARK 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI d27a85e1-aa88-4c4d-bdd3-37b16e40c0b1 35 fields · synced Jun 6, 2026