Identity
- Trade Name
- Elecsys Digoxin Immunoassay FDA UDI
- Generic Name
- Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay FDA UDI
- Model / Reference
- 11820796160 FDA UDI
Identifiers
- Catalog Number
- 11820796160 FDA UDI
- Primary DI / UDI-DI
- 04015630946761 FDA UDI
- 510(k) Number
- K153301 FDA UDI
- FDA Product Code
- KXT FDA UDI
- GMDN Term
- Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3320 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
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: Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
Elecsys Digoxin Immunoassay by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay.
- DIG AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
- ADVIA Centaur® DIG +B — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- DIG AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- ARCHITECT — Abbott · Class II
- Dimension Vista® Flex® reagent cartridge DIGXN — Siemens Healthcare Diagnostics · Class II
- Atellica IM Dig — Siemens Healthcare Diagnostics · Class II
- IMMULITE® 2000 Systems DGX Digoxin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K153301 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 3979245c-a666-48c3-b832-fd0bc606bb8d 35 fields · synced May 30, 2026