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OC-Light S

FDA UDI

Class II (US FDA UDI)

by Polymedco Cancer Diagnostic Products Llc

Identity

Trade Name
OC-Light S FDA UDI
Generic Name
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Personal Use Kit OC-Light S, Custom Kit for (Cambridge Care Center) Somerville Pediatrics FDA UDI
Model / Reference
FBPUS-CHA SP FDA UDI
Description
Personal Use Kit OC-Light S, Custom Kit for (Cambridge Care Center) Somerville Pediatrics FDA UDI

Identifiers

Primary DI / UDI-DI
00816917020907 FDA UDI
510(k) Number
K143325 FDA UDI
FDA Product Code
KHE FDA UDI
GMDN Term
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.6550 FDA UDI
Commercial Distribution
Not 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

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

OC-Light S by Polymedco Cancer Diagnostic Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K143325 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 f9935288-fcb3-428e-b012-bbd7edcbcb51 36 fields · synced May 30, 2026