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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
Personal Use Kit OC-Auto, for Renown FDA UDI
Model / Reference
OCPU-RWN FDA UDI
Description
Personal Use Kit OC-Auto, for Renown FDA UDI

Identifiers

Primary DI / UDI-DI
00816917021065 FDA UDI
510(k) Number
K041408 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

Personal Use Kit OC-Auto, for Renown. An automated occult blood analyzer designed for personal use in Hematology.

Similar devices

Also classified as Faecal occult blood IVD, reagent.

Cleared under the same submission

K041408 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 261ce01f-def4-445a-9747-e0dd1c46a295 35 fields · synced Jul 31, 2026