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: Buffer for OC-Auto Micro 80 iFOB 1 x 200 mL FDA UDI
Model / Reference: OC80B FDA UDI
Description: Buffer for OC-Auto Micro 80 iFOB 1 x 200 mL FDA UDI

Identifiers

Primary DI / UDI-DI: 00855574005124 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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

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Cologuard Hemoglobin Bead Based Assay Reagents Kit — EXACT SCIENCES CORPORATION · Class III
Seracult Patient Kit Fecal Occult Blood Test — Propper Manufacturing Co., Inc. · Class II
OC-Auto — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Class II
OC-Auto — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Polymedco Cancer Diagnostic Products Llc

Sources (1)

FDA UDI ffcccc8c-2c45-4068-abcb-b6fc9b577ddd 35 fields · synced May 30, 2026

OC-Auto

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)