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PENTAPHARM AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10003408661000340866PENTAPHARM AG1N2026-01-01Dornacherstr. 112 Aesch Basel-Landschaft CH 4147

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07640175460013Pefakit - Plasma based functional assay for the determination of resistance to activated protein C caused by the Factor V Leiden mutation (FV:Q506).+41617064848pentapharm@pentapharm.com
07640175460020Pefakit - Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506).+41617064848pentapharm@pentapharm.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
247811370545174K042762PEFAKIT APC-R FACTOR V LEIDENGGW2004-12-22
247811234989797K042760PEFAKIT APC-R FACTOR V LEIDEN CONTROLSGGN2004-12-22
247811384542349
247811405681160
247811544838284
247811787071772

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GGW12004-12-22
GGN12004-12-22

GUDID#