sFlT-1 CalSet 05109531190

GUDID 04015630924288

Roche Diagnostics GmbH

Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, calibrator
Primary Device ID04015630924288
NIH Device Record Keyf5d6cfc9-8a2a-454f-9c28-d2a61377a79a
Commercial Distribution StatusIn Commercial Distribution
Brand NamesFlT-1 CalSet
Version Model Number05109531190
Catalog Number05109531190
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
GS104015630924288 [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

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04015630924288 - sFlT-1 CalSet2025-04-15
04015630925407 - CalSet PlGF2025-04-15
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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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