Identity
- Trade Name
- ACCUTEST Rapid Mono Test FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Rapid Mono Test Device. (Whole Blood/Serum/Plasma) FDA UDI
- Model / Reference
- ID516 FDA UDI
- Description
- Rapid Mono Test Device. (Whole Blood/Serum/Plasma) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10763924516299 FDA UDI
- 510(k) Number
- K961024 FDA UDI
- FDA Product Code
- KTN FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) 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
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: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
ACCUTEST Rapid Mono Test by Jant Pharmacal Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit — Gold Standard Diagnostics, LLC · Class I
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- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- Platelia — CLARK LABORATORIES, INC. · Class I
- Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit — Gold Standard Diagnostics, LLC · Class I
- SeraQuest — QUEST INTERNATIONAL, INC. · Class I
- ELISA EBV-VCA IgM Q Test System — ZEUS SCIENTIFIC, INC.
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
- Jant Pharmacal Corp.
Sources (1)
- FDA UDI dfc3a0ac-cc9b-4449-8776-e07f04e172a2 34 fields · synced May 30, 2026