Identity
- Trade Name
- Diamedix FDA UDI
- Generic Name
- Anti-E [RH0003] antibody screen IVD, control FDA UDI
- Device Name
- "720-480 anti-Cardiolipin Screen" FDA UDI
- Model / Reference
- 720-480 FDA UDI
- Description
- "720-480 anti-Cardiolipin Screen" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817273020280 FDA UDI
- 510(k) Number
- K983553 FDA UDI
- FDA Product Code
- JZO FDA UDI
- GMDN Term
- Anti-E [RH0003] antibody screen IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5870 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: Anti-E [RH0003] antibody screen IVD, control
Diamedix by Diamedix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K983553 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 eb11f4cc-0925-4eb1-ba4c-2770b12b7cc5 36 fields · synced Jun 8, 2026