Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma. FDA UDI
- Model / Reference
- MON-13C15 FDA UDI
- Description
- Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma. FDA UDI
Identifiers
- Catalog Number
- MON-13C15 FDA UDI
- Primary DI / UDI-DI
- 00722066000311 FDA UDI
- 510(k) Number
- K042272 FDA UDI
- FDA Product Code
- KTN FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5640 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
Yes
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: Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Rapid Response by BTNX Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI d7903044-3178-4f83-9bcb-ffd37c8ae105 35 fields · synced Jun 6, 2026