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Rap/Tac/CsA Control 280-1

by More Diagnostics Inc

Rap/Tac/CsA Control 280-1 is a Class I device made by More Diagnostics Inc, cleared under FDA 510(k) K050125 on 18 Mar 2005 and listed in FDA GUDID since 5 Apr 2018 (UDI-DI 00856743007123), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K050125

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 Number00856743007123 UDI-DI Date5 Apr 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050125 Date18 Mar 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050125 decided 18 Mar 2005 Active
  • FDA GUDID UDI-DI 00856743007123 listed 5 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050125
  2. Listed FDA GUDID 00856743007123

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rap/Tac/CsA Control
Generic name
Multiple immunosuppressant therapeutic drug monitoring IVD, control
Model / Ref / Catalog
280-1
Primary DI / UDI-DI
00856743007123
510(k) Number
FDA product code
JJY
GMDN term
Multiple immunosuppressant therapeutic drug monitoring IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Multiple immunosuppressant therapeutic drug monitoring IVD, control

Cleared under the same submission (K050125)

and 5 more cleared under K050125

Similar devices

Other devices filed under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)).

Other devices from More Diagnostics Inc

See all devices from More Diagnostics Inc →

Properties

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