Manufacturer

Ortho-Clinical Diagnostics Dba Quidel

United StatesLegal entities : Ortho-Clinical Diagnostics, Inc. (dba Quidel Corporation)

First countries of placing on the market declared in EUDAMED : Austria, Germany, Italy, Northern Ireland

EU representative : MDSS GmbH (Germany)

20 categories, 48 models including 48 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Multiple viruses - multiplex assays - other	W0105070399	D3 Double Duet DFA Respiratory Virus Screening & ID Kit98/79 D3 Duet DFA Influenza A/Respiratory Virus Screening kit98/79 D3 Duet DFA RSV/Respiratory Virus Screening Kit98/79 D3 Respiratory Virus Antigen Control Slides98/79 D3 Ultra 8 DFA Respiratory Virus Screening & Identification Kit98/79 8 others D3 Ultra DFA Influenza A / Influenza B 10 mL Reagent Set98/79 D3 Ultra DFA Influenza A / Influenza B 2 mL Reagent Set98/79 D3 Ultra DFA Parainfluenza Reagent Set98/79 D3 Ultra DFA Respiratory Virus Direct Specimen Screening set98/79 D3 Ultra DFA Respiratory Virus ID Set98/79 D3 Ultra DFA Respiratory Virus Screening and Identification kit98/79 D3 Ultra DFA Respiratory Virus Shell Vial Screening Set98/79 D3 Ultra DFA RSV Reagent Set98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Lyra Influenza A+B Assay98/79 Lyra Parainfluenza Virus Assay98/79 Quidel Molecular Influenza A+B Control Set98/79 Quidel Molecular Parainfluenza Virus Control Set98/79	– 98/79	EUDAMED record Report an error
Chlamydia reagents - other	W0105010199	D3 Chlamydia trachomatis, LGV Strain98/79 D3 Chlamydia Training Panel98/79 D3 DFA Chlamydiae Culture Confirmation Kit98/79	– 98/79	EUDAMED record Report an error
Cmv reagents - other	W0105040299	D3 CMV Antigen Control Slides98/79 D3 CMV Training Panel98/79 D3 CMV Training Stock98/79	– 98/79	EUDAMED record Report an error
Controls infectious immunology - RT & POC	W0105094001	Savanna RVP Control Set98/79 Savanna RVP Control Set (1-set)98/79 Savanna RVP Control Set (4-set)98/79	– 98/79	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	Lyra RSV+HMPV Assay98/79 Quidel Molecular RSV+hMPV Control Set98/79 Savanna RVP4 Assay98/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Lyra Adenovirus Assay98/79 Quidel Molecular Adenovirus Control Set98/79	– 98/79	EUDAMED record Report an error
Campylobacter detection by NA reagents	W0105011402	Lyra Direct C. difficile Assay98/79 Quidel Molecular C. difficile Control Set98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	Lyra Direct SARS-CoV-298/79 Lyra SARS-CoV-2 Assay98/79	– 98/79	EUDAMED record Report an error
Human metapneumovirus	W0105040617	D3 DFA Metapneumovirus Identification Kit98/79 D3 hMPV Antigen Control Slides98/79	– 98/79	EUDAMED record Report an error
Streptococcal detection by NA reagents	W0105011102	Lyra Direct Strep Assay98/79 Quidel Molecular Step A+G Control Set98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antigen detection	W0105010107	D3 Chlamydia Antigen Control Slides98/79	– 98/79	EUDAMED record Report an error
Cmv antigen	W0105040201	D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit98/79	– 98/79	EUDAMED record Report an error
Enterovirus	W0105040602	D3 IFA Enterovirus Identification Kit98/79	– 98/79	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	D3 Enterovirus Reagent Duo Pack98/79	– 98/79	EUDAMED record Report an error
Laboratory hotplates	W02079012	Quidel Digital Heat Block	A IVDR	EUDAMED record Report an error
Nucleic acid testing apparatuses - rapid and point of care tests	W02050301	Savanna Instrument	A IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Solana Instrument	A IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	D3 RSV Antigen Control Slides98/79	– 98/79	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	D3 Enterovirus Antigen Control Slides98/79	– 98/79	EUDAMED record Report an error

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