Identity
- Trade Name
- D CAL 3 Kit FDA UDI
- Generic Name
- Nucleic acid amplification mastermix kit IVD FDA UDI
- Model / Reference
- 100306 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858637005475 FDA UDI
- PMA Number
- P130017 FDA UDI
- FDA Product Code
- PHP FDA UDI
- GMDN Term
- Nucleic acid amplification mastermix 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 amplification mastermix kit IVD
D CAL 3 Kit by Exact Sciences Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nucleic acid amplification mastermix kit IVD.
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- Spartan RX CYP2C19 System — Spartan Bioscience, Inc. · Class II
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- MGB Alert Platinum Master Mix, 09N41-005 — ELITechGroup MDX LLC. · 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 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 d3a31fd3-ad2e-408b-8286-6b8bc33000a9 33 fields · synced May 30, 2026