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Atellica IM BRAHMS PCT

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM BRAHMS PCT FDA UDI
Generic Name
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Procalcitonin (PCT) Atellica IM - RGT 100T FDA UDI
Model / Reference
11202699 FDA UDI
Description
Procalcitonin (PCT) Atellica IM - RGT 100T FDA UDI

Identifiers

Catalog Number
11202699 FDA UDI
Primary DI / UDI-DI
00630414246550 FDA UDI
510(k) Number
K181002 FDA UDI
FDA Product Code
PRI FDA UDI
PTF FDA UDI
PMT FDA UDI
GMDN Term
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Atellica IM 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, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI f472ae26-b985-4d55-a8cc-4e3624813a01 37 fields · synced Jun 8, 2026