Identity
- Trade Name
- D3 FDA UDI
- Generic Name
- Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- CMV IEA MAB CONJUGATE FDA UDI
- Model / Reference
- 01-075010 FDA UDI
- Description
- CMV IEA MAB CONJUGATE FDA UDI
Identifiers
- Catalog Number
- 01-075010 FDA UDI
- Primary DI / UDI-DI
- 30014613330677 FDA UDI
- FDA Product Code
- LIN FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
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: Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay
D3 by Diagnostic Hybrids, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay.
- Cytomegalovirus 10wl/10 pk — Scimedx Corp. · Class II
- D3 — DIAGNOSTIC HYBRIDS, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA UDI 1e01374d-cef1-424f-a915-c1b3e260d008 35 fields · synced Jun 8, 2026