Identity
- Trade Name
- Alpha-Tec Systems FDA UDI
- Generic Name
- Faecal specimen collection kit IVD, home-use FDA UDI
- Device Name
- SAF/ETM/Clean Microvials bag kit FDA UDI
- Model / Reference
- 0 FDA UDI
- Description
- SAF/ETM/Clean Microvials bag kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816085022260 FDA UDI
- FDA Product Code
- IGB FDA UDI
- GMDN Term
- Faecal specimen collection kit IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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
Yes
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, home-use
Alpha-Tec Systems by Alpha-Tec Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal specimen collection kit IVD, home-use.
- InSure® ONE™ — ENTERIX INC. · Class II
- Colon Cancer Screening Test — Cue Health Inc. · Class I
- InSure® ONE™ — ENTERIX INC. · Class II
- LetsGetChecked Stool Sample Collection Kit — PRIVAPATH DIAGNOSTICS LIMITED · Class I
- FIT-CHEK — HOME ACCESS HEALTH CORP.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Everlywell FIT Kit — Everly Health, Inc. · Class I
- Cologuard Collection Kit — EXACT SCIENCES CORPORATION · Class III
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alpha-Tec Systems, Inc.
Sources (1)
- FDA UDI 96b1472b-fc2b-4d66-af6d-c6e5a75c1652 33 fields · synced May 31, 2026