Identity
- Trade Name
- Diamedix FDA UDI
- Generic Name
- Multiple extractable nuclear antigen (ENA) IVD, reagent FDA UDI
- Device Name
- 720-230 ENA-6 Screen Test Kit FDA UDI
- Model / Reference
- 720-230 FDA UDI
- Description
- 720-230 ENA-6 Screen Test Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817273020068 FDA UDI
- 510(k) Number
- K980759 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen (ENA) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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: Multiple extractable nuclear antigen (ENA) IVD, reagent
Diamedix by Diamedix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple extractable nuclear antigen (ENA) IVD, reagent.
- Autoimmune EIA — Bio-Rad Laboratories · Class II
Cleared under the same submission
K980759 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
- Diamedix Corp.
Sources (1)
- FDA UDI 1d9e2c40-c398-4085-96a6-508233004271 36 fields · synced Jun 6, 2026