Identity
- Trade Name
- RSV Negative Control FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Model / Reference
- RSN-9010 FDA UDI
Identifiers
- Catalog Number
- RSN-9010 FDA UDI
- Primary DI / UDI-DI
- B110RSN90100 FDA UDI
- 510(k) Number
- K894623 FDA UDI
- FDA Product Code
- LKT FDA UDI
- GMDN Term
- Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3480 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
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: Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control
RSV Negative Control by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control.
- RSV IgG Control — BION ENTERPRISES, LTD. · Class I
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI 0ac9a5fa-2aac-4300-9d9f-8c29c19582aa 36 fields · synced May 30, 2026