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HomeMERIDIAN BIOSCIENCE, INC. › Alethia™ Mycoplasma Direct External Control Kit

Alethia™ Mycoplasma Direct External Control Kit

MERIDIAN BIOSCIENCE, INC. · Model 479890 · UDI-DI 00840733102103

OZXOOI Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
12
Facilities

Description

The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.

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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.