PRI

Product Code: PRI


Products Classified as PRI

3578Procalcitonin AssayDevice To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis.

Total Product Life Cycle (TPLC) Devices

3578Procalcitonin AssayDevice To Detect And Measure Non-microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis.

Pre-market Notifications for PRI

K220262Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.
K210254MeMed BVMeMed Diagnostics Ltd.
K192815Elecsys BRAHMS PCTRoche Diagnostics
K173927Elecsys BRAHMS PCTRoche Diagnostics
K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin Inc.
K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators SetFujirebio Diagnostics, Inc.
K171338B R A H M S PCT Sensitive KRYPTORB.R.A.H.M.S GmbH
K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsFisher Diagnostics
K162827VIDAS B.R.A.H.M.S. PCT (PCT)BioMerieux, Inc

Global Unique Device Identification Database

00630414246550Procalcitonin assay
07613336166642Procalcitonin assay
07613336166635Procalcitonin assay

Maude Adverse Events

VIDAS? B?R?A?H?M?S PCT?BIOMERIEUX SA2020-01-31
VIDAS? B?R?A?H?M?S PCT?BIOMERIEUX SA2020-01-31
VIDAS? BRAHMS PROCALCITONIN 60T - 30450-01BIOMERIEUX SA2019-12-20
VIDAS? BRAHAMS PROCALCITONINBIOMERIEUX SA2019-11-08
VIDAS? BRAHAMS PROCALCITONINBIOMERIEUX SA2019-09-16
VIDAS? BRAHAMS PROCALCITONINBIOMERIEUX SA2019-06-04
VIDAS? BRAHMS PROCALCITONINBIOMERIEUX SA2018-12-05
AU680 CLINICAL CHEMISTRY ANALYZERBECKMAN COULTER2018-11-14
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2018-02-27

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