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OC-Auto

FDA UDI

Class II (US FDA UDI)

by Polymedco Cancer Diagnostic Products Llc

Identity

Trade Name
OC-Auto FDA UDI
Generic Name
Faecal occult blood IVD, reagent FDA UDI
Device Name
Latex Reagent for OC-Auto SENSOR io iFOB 2 x 7 mL FDA UDI
Model / Reference
OCIOL FDA UDI
Description
Latex Reagent for OC-Auto SENSOR io iFOB 2 x 7 mL FDA UDI

Identifiers

Primary DI / UDI-DI
00816917025117 FDA UDI
510(k) Number
K191147 FDA UDI
FDA Product Code
OOX FDA UDI
GMDN Term
Faecal occult blood IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.6550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Category: Faecal occult blood IVD, reagent

OC-Auto by Polymedco Cancer Diagnostic Products Llc — Class II — 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

K191147 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Polymedco Cancer Diagnostic Products Llc

Sources (1)

  • FDA UDI 1545e004-ce59-485d-8951-da793d85b38e 35 fields · synced Jun 8, 2026