← Back to catalogue

HB CAL Kit

FDA UDI

Class III (US FDA UDI)

by Exact Sciences Corporation

Identity

Trade Name
HB CAL Kit FDA UDI
Generic Name
Faecal occult blood IVD, reagent FDA UDI
Model / Reference
100325 FDA UDI

Identifiers

Primary DI / UDI-DI
00858637005666 FDA UDI
PMA Number
P130017 FDA UDI
FDA Product Code
PHP FDA UDI
GMDN Term
Faecal occult blood IVD, reagent 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: Faecal occult blood IVD, reagent

HB CAL Kit by Exact Sciences Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal occult blood IVD, reagent.

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 4a6cbf2a-76e9-4e6a-94cd-37ddb98ef96b 33 fields · synced May 30, 2026