Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006413195

FEI Number

3006413195

Entity Name

PROGENIKA BIOPHARMA S.A.

City/State/Country

Derio Vizcaya, ES

Establishment Address

Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia, Derio Vizcaya 48160, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Progenika Biopharma S.A. (Owner Number: 10056259)

Owner / Operator Contact Address

Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia, Derio, ES-BI 48160, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

BP170154

All Registered Proprietary Names

ID CORE CONTROL A1AT Genotyping Test ORAcollectDx OCD-10014 ID CORE XT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PFK	Quality Control For Molecular Immunohematology Tests	Hematology	Class 2	864.9650	2018-11-05
PZH	Serpina1 Variant Detection System	Immunology	Class 2	866.5130	2021-10-25
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2022-11-11
PEP	Molecular Erythrocyte Typing Test	Unknown	Class 3	N/A	2018-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

Alisha McReynolds Business: GRIFOLS Email: alisha.mcreynolds@grifols.com Phone: (510) 9235046

Related Public Records

Same Entity

Progenika Biopharma S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006413195. Last updated year: 2026. Please use registration number 3006413195 when referencing this establishment in official correspondence.