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Prospect Giardia/Cryptosporidium Microplate Assay

by Alexon Biomedical, Inc.

510(k) K955157

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955157 Date9 Feb 1996ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1375-04 FDA Unclassified (pre-2012) initiated 9 Dec 2003

    The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.

    • Terminated Z-1374-04 FDA Unclassified (pre-2012) initiated 21 Nov 2002

    The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates.

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  • Withdrawn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
MHI
Device Class
Class II
Regulation
21 CFR Part 866.3220
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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