Device Listing 1032100462

Listing Summary#

Listing key: 1032100462
Premarket submission: DEN210038
Device: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: QVP
Decision date: 2023-05-05

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
312290	1319681	1000136573	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	100 Indigo Creek Dr Rochester NY US 14626
312213	2250051	2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	1001 US Highway 202 RARITAN NJ US 08869
312670	3000308930	3000308930	Ortho-Clinical Diagnostics European Support Center	1	N	2026-01-01	1500 Boulevard Sebastien Brant B.P. 30335 Illkirch, CEDEX Bas-Rhin FR 67411
312288	3002642396	3002642396	Ortho Clinical Diagnostics	1	N	2026-01-01	1 International Business Park, The Synergy #01-11/12 Singapore South West SG 609917
312720	3007111389	3007111389	Ortho-Clinical Diagnostics	1	N	2026-01-01	Felindre Meadows Pencoed Bridgend GB CF35 5PZ
312609	3012963943	3012963943	Marlene Hanna	1	N	2026-01-01	100 Indigo Creek Dr Rochester NY US 14626