FDA Device Intelligence
Home › HARDY DIAGNOSTICS › N/A

N/A

HARDY DIAGNOSTICS · Model A68 · UDI-DI 00816576024216

KZI
10
510(k) clearances
3,147
Adverse events
2
Recalls
17
Facilities

Description

RTF Agar (Modified Casman), 15x100mm Plate, 17ml. Hardy Diagnostics RTF Agar is recommended for the cultivation and differentiation of fastidious microorganisms, especially Haemophilus spp. by hemolytic reaction.

Recalls

DateFirmReason
2009-02-19Becton Dickinson & Co.In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
2004-09-27Remel, Inc.The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.