Identity
- Trade Name
- ORTHO FDA UDI
- Generic Name
- Microplate/tube/assay card incubator IVD FDA UDI
- Device Name
- Incubator, KVM Model 120, Refurbished FDA UDI
- Model / Reference
- 934090F FDA UDI
- Description
- Incubator, KVM Model 120, Refurbished FDA UDI
Identifiers
- Catalog Number
- 934090F FDA UDI
- Primary DI / UDI-DI
- 10758750005352 FDA UDI
- FDA Product Code
- MZA FDA UDI
- GMDN Term
- Microplate/tube/assay card incubator 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: Microplate/tube/assay card incubator IVD
Ortho by Ortho-Clinical Diagnostics — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microplate/tube/assay card incubator IVD.
- I-UNICELL Incubator — Shenzhen YHLO Biotech Co., Ltd. · Class II
- DG Therm — DIAGNOSTIC GRIFOLS SA · Class II
- BIO-RAD — Bio-Rad · 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 |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 473c6f39-470e-4f21-bfb3-1f4cd909828f 35 fields · synced May 30, 2026