Lumipulse BRAHMS PCT Controls

FDA UDI

Class II (US FDA UDI)

by Fujirebio Inc.

Identity

Trade Name: Lumipulse BRAHMS PCT Controls FDA UDI
Generic Name: Procalcitonin (PCT) IVD, control FDA UDI
Model / Reference: 234945 FDA UDI

Identifiers

Primary DI / UDI-DI: 04987270234945 FDA UDI
510(k) Number: K172713 FDA UDI
FDA Product Code: NTM FDA UDI
PMT FDA UDI
PRI FDA UDI
GMDN Term: Procalcitonin (PCT) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3210 FDA UDI
866.3215 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: Procalcitonin (PCT) IVD, control

Lumipulse BRAHMS PCT Controls by Fujirebio Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Procalcitonin (PCT) IVD, control.

LIAISON Controls BRAHMS PCT II GEN — Diasorin Inc.
VITROS — Ortho-Clinical Diagnostics · Class II
Atellica IM BRAHMS PCT QC Kit — Siemens Healthcare Diagnostics · Class I
Audit MicroControls Linearity FD Procalcitonin bioMerieux VIDAS and miniVIDAS — Aalto Scientific, Ltd.
Audit MicroControls Linearity FD Procalcitonin for Abbott Systems — Aalto Scientific, Ltd.
Elecsys PCT CalCheck 5 — Roche Diagnostics Corp. · Class I
Alinity — Abbott Ireland Diagnostics · Class I
Atellica IM PCT QC — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

K172713 also covers:

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 Inc.

Sources (1)

FDA UDI cc36f874-7329-489c-9473-63abdd77e597 36 fields · synced Jun 1, 2026