Home › HARDY DIAGNOSTICS › N/A

N/A

HARDY DIAGNOSTICS · Model Z275 · UDI-DI 00819398028677

JTO

510(k) clearances

211

Adverse events

Recalls

Facilities

Description

PYR Test Kit, with 15ml chromogenic solution and test cards, 25 cards that have 3 tests per card, total of 75 tests per kit Hardy Diagnostics PYR Test Kit and PYR Reagent are recommended for the detection of pyrolidonyl arylamidase (also called pyrolidonyl aminopeptidase) activity in certain groups of bacteria, such as Streptococcus pyogenes (group A strep), Enterococcus spp., some coagulase-negative staphylococci, and some Enterobacteriaceae. The card format is easier to handle than disks. Three tests can be performed on one card. Contains: PYR Test Card (25) 00819398027144 PYR Chromagenic Solution 15mL (1) 00819398028660

Recalls

Date	Firm	Reason
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed

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 key Read 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.