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Lumipulse G BRAHMS PCT Immunoreaction Cartridges

FDA UDI

Class II (US FDA UDI)

by Fujirebio Inc.

Identity

Trade Name
Lumipulse G BRAHMS PCT Immunoreaction Cartridges FDA UDI
Generic Name
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
235058 FDA UDI

Identifiers

Primary DI / UDI-DI
04987270235058 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, kit, chemiluminescent immunoassay 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Category: Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K172713 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fujirebio Inc.

Sources (1)

  • FDA UDI a0c977c6-90d7-4208-8fec-cabe98111072 36 fields · synced May 30, 2026