CalSet PlGF 05144701190

GUDID 04015630925407

Roche Diagnostics GmbH

Placental growth factor (PLGF) IVD, calibrator
Primary Device ID04015630925407
NIH Device Record Keydea07623-d8b8-40e2-bc66-c46a203b9daa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalSet PlGF
Version Model Number05144701190
Catalog Number05144701190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630925407 [Primary]

FDA Product Code

JITCalibrator, secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-15
Device Publish Date2025-04-07

Devices Manufactured by Roche Diagnostics GmbH

04015630924288 - sFlT-1 CalSet2025-04-15
04015630925407 - CalSet PlGF2025-04-15
04015630925407 - CalSet PlGF2025-04-15
07613336172094 - Elecsys sFlT-12025-04-15
07613336172124 - Elecsys PlGF2025-04-15
07613336220108 - PreciControl Rubella IgM2025-04-15
07613336230671 - Elecsys sFlT-12025-04-15
07613336230756 - Elecsys PlGF2025-04-15
07613336223321 - Kidney KFRE Algorithm2025-04-08

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