← Back to catalogue

Cologuard Barcoded Mixing Tubes

FDA UDI

Class III (US FDA UDI)

by Exact Sciences Corporation

Identity

Trade Name
Cologuard Barcoded Mixing Tubes FDA UDI
Generic Name
Nucleic acid extraction/isolation kit IVD FDA UDI
Model / Reference
100110 FDA UDI

Identifiers

Primary DI / UDI-DI
00858637005093 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

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

Cologuard Barcoded Mixing Tubes 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Exact Sciences Corporation

Sources (1)

  • FDA UDI 4e2bbfb8-afaf-4520-ba5a-0678c1c60d11 34 fields · synced May 31, 2026