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Cologuard Spin Filter Kit

FDA UDI

Class III (US FDA UDI)

by Exact Sciences Corporation

Identity

Trade Name
Cologuard Spin Filter Kit FDA UDI
Generic Name
Nucleic acid extraction/isolation kit IVD FDA UDI
Model / Reference
100283 FDA UDI

Identifiers

Primary DI / UDI-DI
00858637005208 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
Not 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

Cologuard Spin Filter Kit by Exact Sciences Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P130017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exact Sciences Corporation

Sources (1)

  • FDA UDI 99ca9d5a-cb64-43c7-b973-c4fba0048a43 34 fields · synced Jun 8, 2026