Identity
- Trade Name
- Poly stat FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Mono, Immunochromatographic FDA UDI
- Model / Reference
- MN20 FDA UDI
- Description
- Mono, Immunochromatographic FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816917021546 FDA UDI
- 510(k) Number
- K961024 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
No
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
Poly stat by Polymedco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical.
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Cleared under the same submission
K961024 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 II | Pending data |
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Manufacturer
- Manufacturer
- Polymedco, Inc.
Sources (1)
- FDA UDI 49df58ec-4fed-407b-b211-fbb840e02412 35 fields · synced Jun 8, 2026