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Astra Biotech GmbH

Germany·DE-MF-000026439

Last updated September 18, 2026

About

Astra Biotech’s portfolio of diagnostic products includes a variety of test methods and reagents for the detection of human hormones, allergies, tumor markers, infections and genetic diseases. The IVD tests of Astra Biotech are based on ELISA or qPCR technologies and guarantee the highest sensitivity and specificity in the respective application. All test kits are CE marked and are subject to strict quality control for the safety and well-being of users and patients.

Translated from the manufacturer's own website. Source

Information

Country
Germany
Address
29, Rudower Chaussee , Berlin, Germany
LinkedIn
—
Facebook
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Phone
+49 (0)30-74 696 509
PRRC Contact
Kai Schulze-Forster
EUDAMED SRN
DE-MF-000026439
FDA FEI Number
—
DUNS Number
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Catalogue (9)

DeviceModel / ReferenceRegistriesClassStatus
Total IgE kit 50-01
EUDAMED
IVD GeneralActive
Progesterone kit 21-03A
EUDAMED
IVD GeneralActive
Multi DNA Extraction kit 80-01
EUDAMED
Class AActive
Total IgE 2000 kit 50-03 A
EUDAMED
IVD GeneralActive
Neisseria gonorrhoeae PCR kit (Form F) 84-01
EUDAMED
IVD GeneralActive
Progesterone kit 21-03
EUDAMED
IVD GeneralActive
Rapid DNA Extraction kit 80-07
EUDAMED
Class AActive
Magnetic DNA / RNA Auto Extraction kit 80-08
EUDAMED
Class AActive
Prime DNA/RNA Extraction kit 80-07
EUDAMED
Class AActive

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