Identity
- Trade Name
- BND BDS Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Model / Reference
- 100317 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858637005581 FDA UDI
- PMA Number
- P130017 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
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: Nucleic acid extraction/isolation kit IVD
BND BDS Kit 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.
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- 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
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 Aspirator — 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 0e1c145f-15c0-4c28-a322-f29405f75450 33 fields · synced Jun 1, 2026