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S.G. Calibrator H
ARKRAY USA, INC. · Model 111581 · UDI-DI 04987486053002
JMT
Prescription
10
510(k) clearances
7
Adverse events
2
Recalls
78
Facilities
Description
The S.G. Calibrator H is used for calibration of the S.G. measurement system of the AUTION system. The S.G. Calibrator establishes reference points based on the physical principles of AUTION analyzers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
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Get your free API keyRead the docsData 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.