510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210038Unknown

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

Ortho-Clinical Diagnostics, Inc., Rochester NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN210038 is the FDA 510(k) clearance record for VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code QVP (Sars-Cov-2 Serology Test). FDA's definition for product code QVP reads: "A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying...". FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming DEN210038.

Clearance record

Decision date
Received
(592 days to decision)
Product code
QVP Sars-Cov-2 Serology Test
Regulation
21 CFR 866.3983
Device class
Class II
Review panel
Microbiology
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
Third party review
No

Clearances, product code QVP

Trailing 12 months
2 clearances under product code QVP in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QVP, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260