510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN110001Unknown

Ridascreen Norovirus 3Rd Generation Eia

R-Biopharm AG, East Stroudsburg PA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN110001 is the FDA 510(k) clearance record for RIDASCREEN NOROVIRUS 3RD GENERATION EIA, a class II device, cleared for R-Biopharm AG on under FDA product code OUC (Norovirus Serological Reagent). FDA's definition for product code OUC reads: "Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in...". FDA records list 2 510(k) clearances for R-Biopharm AG, from to . As of , FDA records show no recalls naming DEN110001.

Clearance record

Decision date
Received
(7 days to decision)
Product code
OUC Norovirus Serological Reagent
Regulation
21 CFR 866.3395
Device class
Class II
Review panel
Microbiology
Applicant
R-Biopharm AG 150 Cherry Ln. Rd., East Stroudsburg PA
Third party review
No

Clearances, product code OUC

Trailing 12 months

FDA records hold no clearances under product code OUC in the trailing twelve months.

FDA records show no clearances under product code OUC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260