Identity
- Trade Name
- Dimension Vista® 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, 40 tests FDA UDI
- Model / Reference
- 10482947 FDA UDI
- Description
- Digitoxin Flex® reagent cartridge, 40 tests FDA UDI
Identifiers
- Catalog Number
- K4036A FDA UDI
- Primary DI / UDI-DI
- 00842768033315 FDA UDI
- 510(k) Number
- K062024 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 Vista® 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).
Cleared under the same submission
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 7bfebdf4-56a3-4a65-908c-e274c67f787c 37 fields · synced May 31, 2026