Dm Exl Loci Brahms Pct

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: DM EXL LOCI BRAHMS PCT FDA UDI
Generic Name: Procalcitonin (PCT) IVD, reagent FDA UDI
Device Name: Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT FDA UDI
Model / Reference: 11354447 FDA UDI
Description: Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT FDA UDI

Identifiers

Catalog Number: RF648 FDA UDI
Primary DI / UDI-DI: 00630414238692 FDA UDI
510(k) Number: K220262 FDA UDI
FDA Product Code: PMT FDA UDI
PRI FDA UDI
GMDN Term: Procalcitonin (PCT) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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: Procalcitonin (PCT) IVD, reagent

Dm Exl Loci Brahms Pct by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Procalcitonin (PCT) IVD, reagent.

Diazyme Procalcitonin Assay — Diazyme Laboratories, Inc.
DiaSys Procalcitonin FS — DiaSys Diagnostic Systems GmbH · Class II
Diazyme — Diazyme Laboratories, Inc.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 0e44fd31-1036-4ee8-8989-d61c84331653 37 fields · synced May 30, 2026