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Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820

by Chugai Pharmaceuticals Co., Ltd. 510(k)

Active United States

510(k) K974572

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974572 Date24 Sep 1998ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-1436-2011 FDA Unclassified (pre-2012) initiated 30 Dec 2008

    This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.

    • Terminated Z-0145-2008 FDA Unclassified (pre-2012) initiated 2 May 2007

    Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

Specification

510(k)

510(k) Number
FDA Product Code
MDK
Device Class
Class I
Regulation
21 CFR Part 866.3740
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent