Identity
- Trade Name
- Epi proColon FDA UDI
- Generic Name
- Methylated DNA IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Epi proColon Control Kit FDA UDI
- Model / Reference
- Control Kit FDA UDI
- Description
- Epi proColon Control Kit FDA UDI
Identifiers
- Catalog Number
- M5-02-003 FDA UDI
- Primary DI / UDI-DI
- 04260400670029 FDA UDI
- PMA Number
- P130001 FDA UDI
- FDA Product Code
- PHP FDA UDI
- GMDN Term
- Methylated DNA IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class III 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: Methylated DNA IVD, kit, nucleic acid technique (NAT)
Epi proColon by Epigenomics AG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Methylated DNA IVD, kit, nucleic acid technique (NAT).
- Bladder EpiCheck Test Kit — Nucleix , Ltd. · Class II
- Epi proColon — Epigenomics AG · Class III
- Epi proColon — Epigenomics AG · Class III
Cleared under the same submission
P130001 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 III | Pending data |
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Manufacturer
- Manufacturer
- Epigenomics AG
Sources (1)
- FDA UDI e6efb29c-9a51-49e0-9b99-37a5bac8b198 36 fields · synced May 30, 2026