Identity
- Trade Name
- The Cologuard Plus Collection Kit FDA UDI
- Generic Name
- Faecal specimen collection kit IVD, home-use FDA UDI
- Model / Reference
- 100676 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858637005949 FDA UDI
- PMA Number
- P230043 FDA UDI
- FDA Product Code
- PHP FDA UDI
- GMDN Term
- Faecal specimen collection kit IVD, home-use FDA UDI
Classification
- Device Class
- Class III 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
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, home-use
The Cologuard Plus Collection Kit by Exact Sciences Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P230043 also covers:
- Analysis Client v2.2 — EXACT SCIENCES CORPORATION
- Analysis Server v2.2 — EXACT SCIENCES CORPORATION
- CAP SLN — EXACT SCIENCES CORPORATION
- CG2 BND SLN — EXACT SCIENCES CORPORATION
- CG2 CAP BDS — EXACT SCIENCES CORPORATION
- CG2 CAP WSH — EXACT SCIENCES CORPORATION
- CG2 CNV WSH — EXACT SCIENCES CORPORATION
- CG2 REC BFR — EXACT SCIENCES CORPORATION
- CG2 WSH — EXACT SCIENCES CORPORATION
- Cologuard 2 Test Definition — EXACT SCIENCES CORPORATION
- Cologuard FILT — EXACT SCIENCES CORPORATION
- Cologuard Inhibitor Removal Tablet Kit — EXACT SCIENCES CORPORATION
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 III | Pending data |
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Manufacturer
- Manufacturer
- Exact Sciences Corporation
Sources (1)
- FDA UDI d09d7ca7-e4a5-4f15-b174-79ee69c83463 33 fields · synced May 31, 2026