Identity
- Trade Name
- IMAGEN RESPIRATORY SCREEN POS CON SLIDE FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, control FDA UDI
- Model / Reference
- S612130-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384503070 FDA UDI
- 510(k) Number
- K973954 FDA UDI
- FDA Product Code
- GNW FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, control 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Multiple-genus respiratory virus antigen IVD, control
Imagen Respiratory Screen Pos Con Slide by Oxoid Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus antigen IVD, control.
- BD Veritor™ System Flu A+B Control Swab Set — BECTON DICKINSON AND COMPANY · Class I
- D3 Fastpoint — DIAGNOSTIC HYBRIDS, INC. · Class I
- D3 — DIAGNOSTIC HYBRIDS, INC. · 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
- D3 Fastpoint — DIAGNOSTIC HYBRIDS, INC. · Class I
- OSOM Flu SARS-CoV-2 Combo Control Kit — Sekisui Diagnostics, LLC · N
Cleared under the same submission
K973954 also covers:
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
- Oxoid Limited
Sources (1)
- FDA UDI f6c1f3ce-2f1b-476d-b0a8-c0bb4887d7b9 33 fields · synced Jun 8, 2026