Skip to content

Detector RPR RPR-500NC

by Immunostics

Detector RPR RPR-500NC is a Class II device made by Immunostics, listed in FDA GUDID since 3 Dec 2016 (UDI-DI 10722355001798), registry data as of 8 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10722355001798 UDI-DI Date3 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Detector RPR
Generic name
Treponema pallidum reagin antibody IVD, kit, agglutination
Model / Ref / Catalog
RPR-500NC
Primary DI / UDI-DI
10722355001798
FDA product code
GMQ
GMDN term
Treponema pallidum reagin antibody IVD, kit, agglutination
Device class
Class II
Regulation number
866.3820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Treponema pallidum reagin antibody IVD, kit, agglutination

Similar devices in this category

Other devices filed under Treponema pallidum reagin antibody IVD, kit, agglutination.

Other devices from Immunostics

See all devices from Immunostics →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)