Identity
- Trade Name
- Dimension® Flex® reagent cartridge DGTX FDA UDI
- Generic Name
- Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Digitoxin Flex® reagent cartridge, 80 tests FDA UDI
- Model / Reference
- 10444932 FDA UDI
- Description
- Digitoxin Flex® reagent cartridge, 80 tests FDA UDI
Identifiers
- Catalog Number
- DF36 FDA UDI
- Primary DI / UDI-DI
- 00842768005510 FDA UDI
- 510(k) Number
- K990251 FDA UDI
- FDA Product Code
- LFM FDA UDI
- GMDN Term
- Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3300 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
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: Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Dimension® Flex® reagent cartridge DGTX by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 36494f72-b936-4e9f-9359-5934d0cf8bdf 37 fields · synced May 30, 2026