R-Biopharm Clinical USA Inc.

FDA Device Registration & Listing · Washington, MO, US · Registration 3016548670

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016548670
FEI Number
3016548670
Entity Name
R-Biopharm Clinical USA Inc.
City/State/Country
Washington, MO, US
Establishment Address
870 Vossbrink Dr, Washington, MO 63090, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
R-Biopharm Clinical USA Inc. (Owner Number: 10088745)
Owner / Operator Contact Address
870 Vossbrink Drive, Washington, MO 63090, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RIDA®GENE Norovirus GI/GII RIDA®GENE Norovirus GI/GII RIDA® CCD-Inhibitor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PIQ Reagents For Detection Of Norovirus Nucleic Acid Microbiology Class 2 866.3990 2023-10-19
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2023-10-19
OUC Norovirus Serological Reagent Microbiology Class 2 866.3395 2023-10-19
DHL Protein, Complement, Antigen, Antiserum, Control Immunology Class 1 866.4100 2023-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

R-Biopharm Clinical USA Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016548670. Last updated year: 2026. Please use registration number 3016548670 when referencing this establishment in official correspondence.
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