Identity
- Trade Name
- CG2 CAP BDS FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea) FDA UDI
- Model / Reference
- 100699 FDA UDI
- Description
- Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850057859003 FDA UDI
- PMA Number
- P230043 FDA UDI
- FDA Product Code
- PHP FDA UDI
- GMDN Term
- Nucleic acid extraction/isolation kit IVD 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
No
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: Nucleic acid extraction/isolation kit IVD
Cg2 Cap Bds by Exact Sciences Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 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
- Cologuard STL BFR — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exact Sciences Corporation
Sources (1)
- FDA UDI ebbce599-879c-49b6-b398-50e60be06994 34 fields · synced Jun 1, 2026