Skip to content

Rapid Response ADE-9C20

by BTNX Inc

Rapid Response ADE-9C20 is a Class I device made by BTNX Inc, cleared under FDA 510(k) K990630 on 19 Aug 1999 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00722066001905), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K990630

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00722066001905 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK990630 Date19 Aug 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K990630 decided 19 Aug 1999 Active
  • FDA GUDID UDI-DI 00722066001905 listed 25 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K990630
  2. Listed FDA GUDID 00722066001905

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rapid Response
Generic name
Adenovirus antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
ADE-9C20
Primary DI / UDI-DI
00722066001905
510(k) Number
FDA product code
GOD
GMDN term
Adenovirus antigen IVD, kit, rapid ICT, clinical
Device class
Class I
Regulation number
866.3020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Adenovirus antigen IVD, kit, rapid ICT, clinical

Similar devices

Other devices filed under FDA product code GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33).

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

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