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Is-Rubella Igg Test System

by Diamedix Corp.

510(k) K981729

Is-Rubella Igg Test System is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K981729 on 28 Jan 1999, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981729 Date28 Jan 1999ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LFX
Device class
Class II
Regulation
21 CFR Part 866.3510
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K981729

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K981729
UDI-DISize and differences
Diamedix 720-360
Diamedix Corp.
720-36000817273020198
Prescription: no; Single use: no
On the market
Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit 720-360
Gold Standard Diagnostics, LLC
720-360 / 720-360B3507203600
Prescription: yes; Single use: yes
On the market

Similar devices

Other devices filed under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella).

Other devices from Diamedix Corp.

See all devices from Diamedix Corp. →