Identity
- Trade Name
- Diamedix FDA UDI
- Generic Name
- Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- "720-630 EBNA-1 IgM Test Kit" FDA UDI
- Model / Reference
- 720-630 FDA UDI
- Description
- "720-630 EBNA-1 IgM Test Kit" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817273020341 FDA UDI
- 510(k) Number
- K982352 FDA UDI
- FDA Product Code
- LSE FDA UDI
- GMDN Term
- Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3235 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Diamedix by Diamedix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- Diamedix — Diamedix Corp. · Class I
Cleared under the same submission
K982352 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 I | Pending data |
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Manufacturer
- Manufacturer
- Diamedix Corp.
Sources (1)
- FDA UDI 7dae1a30-9440-4eba-8613-99a7bf73b150 36 fields · synced Jun 8, 2026