PSP Spin Stool DNA Basic Kit (250) 1038120300

GUDID 04250306300427

Invitek Molecular GmbH

Nucleic acid extraction/isolation kit IVD
Primary Device ID04250306300427
NIH Device Record Keybe574a6b-8197-4db5-add8-f9fe4f901bb9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePSP Spin Stool DNA Basic Kit (250)
Version Model Number250 prep
Catalog Number1038120300
Company DUNS331869789
Company NameInvitek Molecular GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104250306300427 [Primary]

FDA Product Code

PFTReagents For Molecular Diagnostic Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-28
Device Publish Date2025-01-20

Devices Manufactured by Invitek Molecular GmbH

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04250306300229 - InviTrap Spin Universal RNA Kit (250)2025-01-28 Kit design for isolation of RNA from various samples.
04250306300311 - RTP Pathogen Kit (50)2025-01-28
04250306300328 - RTP Pathogen Kit (250)2025-01-28
04250306300410 - PSP Spin Stool DNA Basic Kit (50)2025-01-28
04250306300427 - PSP Spin Stool DNA Basic Kit (250)2025-01-28
04250306300427 - PSP Spin Stool DNA Basic Kit (250)2025-01-28
04250306300922 - PSP SalivaGene DNA Kit (250)2025-01-28

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