Elecsys BRAHMS PCT 08828679190

GUDID 07613336166642

Roche Diagnostics GmbH

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336166642
NIH Device Record Keybf523dc2-023b-43fa-b97a-19408709fa4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys BRAHMS PCT
Version Model Number08828679190
Catalog Number08828679190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336166642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PRIProcalcitonin assay

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

On-Brand Devices [Elecsys BRAHMS PCT]

0761333616664208828679190
0761333616663508828644190

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