Identity
- Trade Name
- Cologuard Capture Aspirator FDA UDI
- Generic Name
- Pipetting system IVD FDA UDI
- Model / Reference
- 300490 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858637005895 FDA UDI
- PMA Number
- P130017 FDA UDI
- FDA Product Code
- JQW FDA UDI
- GMDN Term
- Pipetting system IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2750 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pipetting system IVD
Cologuard Capture Aspirator by Exact Sciences Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pipetting system IVD.
- AcfS Library Robot — Roche Molecular Systems, Inc. · Class I
- ESH, "CE", (New Computer) — Helena Laboratories, Corp. · Class I
- Freedom EVO® — Tecan Schweiz AG · N
- Freedom EVO® — Tecan Schweiz AG · N
- AcfS Detection Robot — Roche Molecular Systems, Inc. · Class I
- AcfS L and D Equipment Installation Bundle — Roche Molecular Systems, Inc. · Class I
- ESH Touch (120/230V) — Helena Laboratories, Corp. · Class I
- Procleix Xpress® System — Grifols Diagnostic Solutions Inc. · Class I
Cleared under the same submission
P130017 also covers:
- Analysis Client v2.2 — EXACT SCIENCES CORPORATION
- Analytical Client — EXACT SCIENCES CORPORATION
- Analytical Server — EXACT SCIENCES CORPORATION
- BIS SLN Kit — EXACT SCIENCES CORPORATION
- CAP BDS Kit — EXACT SCIENCES CORPORATION
- CAP SLN — EXACT SCIENCES CORPORATION
- CAR SLN Kit — EXACT SCIENCES CORPORATION
- CNV WSH Kit — EXACT SCIENCES CORPORATION
- CONJ Kit — EXACT SCIENCES CORPORATION
- Cologuard Binding Solution — EXACT SCIENCES CORPORATION
- Cologuard Binding Solution Kit — EXACT SCIENCES CORPORATION
- Cologuard Capture Bead Pre-Wash — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exact Sciences Corporation
Sources (1)
- FDA UDI eabcef8e-e4ad-4ced-a47d-6affacd42198 33 fields · synced May 30, 2026