Identity
- Trade Name
- Speedy Tests FDA UDI
- Generic Name
- Disopyramide therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- Speedy Tests DOA Single Test Dipcard, 25Pcs/Box mAMP FDA UDI
- Model / Reference
- STDIPMA-25 FDA UDI
- Description
- Speedy Tests DOA Single Test Dipcard, 25Pcs/Box mAMP FDA UDI
Identifiers
- Catalog Number
- STDIPMA-25 FDA UDI
- Primary DI / UDI-DI
- 10866415000311 FDA UDI
- FDA Product Code
- DJC FDA UDI
- GMDN Term
- Disopyramide therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3610 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
Yes
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: Disopyramide therapeutic drug monitoring IVD, calibrator
Speedy Tests by Speedy Solutions Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Speedy Solutions Llc
Sources (1)
- FDA UDI 204b5b0d-34b5-4886-95f5-eb68f31b7af8 34 fields · synced May 30, 2026