Identity
- Trade Name
- ORTHO FDA UDI
- Generic Name
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
- Device Name
- ORTHO VERSEIA™ Pipetter Workstation - computer FDA UDI
- Model / Reference
- 6842852 FDA UDI
- Description
- ORTHO VERSEIA™ Pipetter Workstation - computer FDA UDI
Identifiers
- Catalog Number
- 6842852 FDA UDI
- Primary DI / UDI-DI
- 10758750011582 FDA UDI
- FDA Product Code
- MZA FDA UDI
- GMDN Term
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
Classification
- Device Class
- N 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Enzyme immunoassay (EIA) analyser IVD
Ortho by Ortho-Clinical Diagnostics — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enzyme immunoassay (EIA) analyser IVD.
- EUROLabWorkstation ELISA — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- ThunderBolt EIA (CLIA) — Gold Standard Diagnostics, LLC · Class I
- CHORUS TRIO — DIESSE DIAGNOSTICA SENESE SPA · Class I
- Bolt (CLIA) — Gold Standard Diagnostics, LLC · Class I
- UNION Immune Analyzer — Shenzhen YHLO Biotech Co., Ltd. · Class I
- EUROBlotOne — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- PR 4100 — Bio-Rad · Class I
- Performance Check Dye Kit — Gold Standard Diagnostics, LLC · Class I
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 N | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 2f7cd850-9060-40a8-9e01-0669ab140759 35 fields · synced May 31, 2026