Beckman Coulter PK TP System Control Set

FDA UDI

Class II (US FDA UDI)

by Fujirebio Diagnostics, Inc.

Identity

Trade Name: Beckman Coulter PK TP System Control Set FDA UDI
Generic Name: Treponema pallidum total antibody IVD, control FDA UDI
Model / Reference: PH3502 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850212007041 FDA UDI
FDA Product Code: KSF FDA UDI
GMDN Term: Treponema pallidum total antibody IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9650 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Treponema pallidum total antibody IVD, control

Beckman Coulter PK TP System Control Set by Fujirebio Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Fujirebio Diagnostics, Inc.

Sources (1)

FDA UDI 653781ec-764b-468e-8068-f780fcf4af6d 35 fields · synced Jun 9, 2026