Identity
- Trade Name
- D3 Ultra FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- D3 Ultra DFA Respiratory Virus ID Set FDA UDI
- Model / Reference
- 01-010007.V2 FDA UDI
- Description
- D3 Ultra DFA Respiratory Virus ID Set FDA UDI
Identifiers
- Catalog Number
- 01-010007.V2 FDA UDI
- Primary DI / UDI-DI
- 30014613330356 FDA UDI
- 510(k) Number
- K092300 FDA UDI
- FDA Product Code
- GNW FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3330 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
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: Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092300 also covers:
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC.
- D3 Ultra — DIAGNOSTIC HYBRIDS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA UDI e456325f-4211-4f29-9a0e-5a9e2b58a806 36 fields · synced May 30, 2026