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Modified Ddi Serocard Herpes Igg Test Kit

by Disease Detection International, Inc. 510(k)

Active United States

510(k) K884246

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884246 Date10 Apr 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 9 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LGC
Device Class
Class II
Regulation
21 CFR Part 866.3305
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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