Identity
- Trade Name
- Fecal Extraction Device FDA UDI
- Generic Name
- Faecal specimen collection kit IVD, clinical FDA UDI
- Device Name
- -100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps FDA UDI
- Model / Reference
- 504837 FDA UDI
- Description
- -100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950846833 FDA UDI
- FDA Product Code
- NXO FDA UDI
- GMDN Term
- Faecal specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5180 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: Faecal specimen collection kit IVD, clinical
Fecal Extraction Device by Inova Diagnostics, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (2)
- FDA UDI 7c7c3833-a787-40b6-893d-29f8acfbed1b 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026