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Diamedix 300-371A

by Diamedix Corp.

Diamedix 300-371A is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K980759 on 23 Apr 1998 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020044), active as of 22 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K980759

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 Number00817273020044 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK980759 Date23 Apr 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K980759 decided 23 Apr 1998 Active
  • FDA GUDID UDI-DI 00817273020044 listed 20 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1620-2012 FDA Unclassified (pre-2012) initiated 8 Jun 2011

    On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date.

Timeline

3 dated events

  1. Cleared FDA 510(k) K980759
  2. Recall initiated FDA recalls Z-1620-2012
  3. Listed FDA GUDID 00817273020044

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diamedix
Generic name
Multiple infectious organism/newborn TORCH screen IVD, kit, enzyme immunoassay (EIA)
Model / reference
300-371A
Description
"300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"
Primary DI / UDI-DI
00817273020044
510(k) Number
FDA product code
LLL
GMDN term
Multiple infectious organism/newborn TORCH screen IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple infectious organism/newborn TORCH screen IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K980759)

Similar devices

Other devices filed under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control).

Other devices from Diamedix Corp.

See all devices from Diamedix Corp. →

Properties

  • Convenience kit
  • Lot / batch number
Other properties (13, all answered No)