Manufacturer

Cepheid

Sweden, United StatesLegal entities : Cepheid AB

Markets : France · Italy · Netherlands · Poland · Sweden · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 66 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : Poland 26 · Italy 10 · France 3 · Sweden 1

EU representative : Cepheid AB (Sweden)

Website

19 categories, 22 models including 22 on the market, 2 countries

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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
Coronavirus - NA reagents	W0105041106	Xpert® Xpress CoV-2 plus98/79 Xpert® Xpress SARS-CoV-298/79	– 98/79	EUDAMED record Report an error
HIV 1 - NA reagents	W0105030107	Xpert® HIV-1 Qual XC98/79 Xpert® HIV-1 Viral Load XC98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Xpert®98/79 Xpert® Xpress CoV-2/Flu/RSV plus98/79	– 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	Xpert®2 refs98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Xpert®	B IVDR	EUDAMED record Report an error
Hepatitis b virus - NA reagents	W0105020216	Xpert®98/79	– 98/79	EUDAMED record Report an error
Hepatitis c virus - NA reagents	W0105020307	Xpert®2 refs98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Xpert®98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	Xpert®3 refs98/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	Xpert®98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	Xpert®	A IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	GeneXpert5 refs	A IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Xpert®	A IVDR	EUDAMED record Report an error
Screening high-risk HPV - NA reagents	W0105041002	Xpert®98/79	– 98/79	EUDAMED record Report an error
Staphylococcal detection by NA reagents	W0105011203	Xpert®3 refs98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	Xpert®4 refs98/79	– 98/79	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	Xpert®98/79	– 98/79	EUDAMED record Report an error
Strep. b detection by NA reagents	W0105011104	Xpert®3 refs	C IVDR, 98/79	EUDAMED record Report an error
Urine collection devices - other	W05010299	Xpert®2 refs	A IVDR	EUDAMED record Report an error

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