Identity
- Trade Name
- D3 FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) antigen IVD, control FDA UDI
- Device Name
- RSV Antigen Control Slides FDA UDI
- Model / Reference
- 01-00050 FDA UDI
- Description
- RSV Antigen Control Slides FDA UDI
Identifiers
- Catalog Number
- 01-00050 FDA UDI
- Primary DI / UDI-DI
- 30014613330240 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Respiratory syncytial virus (RSV) 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: Respiratory syncytial virus (RSV) antigen IVD, control
D3 by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory syncytial virus (RSV) antigen IVD, control.
- SAS RSV Control Kit — SA SCIENTIFIC, LTD
- Respiratory Syncytial Virus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD. · Class I
- PathoDX RSV Control Slides — REMEL EUROPE LIMITED · Class I
- Remel Xpect RSV Control — SA SCIENTIFIC, LTD
- RAMP® RSV Control Swabs — Response Biomedical Corp
- Sure-Vue RSV Control Kit — SA SCIENTIFIC, LTD
- BD Veritor™ System RSV Control Swab Set — BECTON DICKINSON AND COMPANY · Class I
- BinaxNOW RSV Control Swab Kit — Alere Scarborough, 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 01a8f6fe-72ed-4af1-af05-baf77cd113ff 35 fields · synced May 30, 2026