← Back to catalogue
Respiratory Virus Panel Antigen Control Slide, 14 wells
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Respiratory Virus Panel Antigen Control Slide, 14 wells FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, control FDA UDI
- Model / Reference
- QRP-6314 FDA UDI
Identifiers
- Catalog Number
- QRP-6314 FDA UDI
- Primary DI / UDI-DI
- B110QRP63140 FDA UDI
- 510(k) Number
- K890616 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
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Respiratory Virus Panel Antigen Control Slide, 14 wells by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K890616 also covers:
- Adenovirus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Chlamydia Antigen Contol Slide (Elem. Bodies), 2 wells — BION ENTERPRISES, LTD.
- Cytomegalovirus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Enterovirus Panel Antigen Control Slide, 4 wells — BION ENTERPRISES, LTD.
- Herpes Simplex Virus Antigen Control Slide, 4 wells — BION ENTERPRISES, LTD.
- Influenza A & B Virus Antigen Control Slide, 4 wells — BION ENTERPRISES, LTD.
- Measles (Rubeola) Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Mumps Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Parainfluenza Virus Antigen Control Slide, 6 wells — BION ENTERPRISES, LTD.
- Respiratory Syncytial Virus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Varicella Zoster Virus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
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
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI 190edcd3-aea8-455e-b14d-0273c6e9687b 37 fields · synced May 30, 2026