Identity
- Trade Name
- D3 Fastpoint FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, control FDA UDI
- Device Name
- L-DFA Influenza A/Influenza B Antigen Control Slides FDA UDI
- Model / Reference
- 01-124110 FDA UDI
- Description
- L-DFA Influenza A/Influenza B Antigen Control Slides FDA UDI
Identifiers
- Catalog Number
- 01-124110 FDA UDI
- Primary DI / UDI-DI
- 30014613338710 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
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: Multiple-genus respiratory virus antigen IVD, control
D3 Fastpoint by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus antigen IVD, control.
- IMAGEN RESPIRATORY SCREEN POS CON SLIDE — OXOID LIMITED · Class I
- BD Veritor™ System Flu A+B Control Swab Set — BECTON DICKINSON AND COMPANY · Class I
- BinaxNOW COVID-19/Flu A&B Controls — Alere Scarborough, Inc. · Class II
- PathoDX RVP Control Slides — REMEL EUROPE LIMITED · Class I
- QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit — OSANG HEALTHCARE Co., Ltd. · Class I
- OSOM Flu SARS-CoV-2 Combo Control Kit — Sekisui Diagnostics, LLC · N
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class I
- D3 Fastpoint — DIAGNOSTIC HYBRIDS, INC. · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA UDI 8bb0eff1-7acd-492d-9064-c413ae6d58a9 35 fields · synced Jun 6, 2026