Manufacturer

Astra Biotech

GermanyLegal entities : Astra Biotech GmbH

Markets : Germany

Approvals : EU – class A

6 categories, 17 models including 17 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Magnetic DNA / RNA Auto Extraction kit Magnetic DNA/RNA Auto Extraction kit (Form P1) Magnetic Plus DNA/RNA Auto Extraction kit Magnetic Plus DNA/RNA Auto Extraction kit (Form P1) Multi DNA Extraction kit 1 other Prime DNA/RNA Extraction kit	A IVDR	EUDAMED record Report an error
Chlamydia trachomatis detection by NA reagents	W0105010117	Chlamydia trachomatis PCR kit (Form F)3 refs98/79 Chlamydia trachomatis PCR kit (Form S)3 refs98/79 Chlamydia trachomatis PCR kit (Form T)3 refs98/79	– 98/79	EUDAMED record Report an error
Ureaplasma detection by NA reagents	W010501080303	Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form F)3 refs98/79 Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form S)2 refs98/79 Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form T)3 refs98/79	– 98/79	EUDAMED record Report an error
Urogenital mycoplasma detection by NA reagents	W010501080302	Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)3 refs98/79 Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form S)3 refs98/79 Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)3 refs98/79	– 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	Neisseria gonorrhoeae PCR kit3 refs98/79	– 98/79	EUDAMED record Report an error
Trichomonas - NA reagents	W0105050310	Trichomonas vaginalis PCR kit3 refs98/79	– 98/79	EUDAMED record Report an error

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