FDA-Device2018-05-02Class III
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Diagnostic Hybrids, Inc.
Hazard
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
Sold states
The product was distributed to the following countries: Singapore, Switzerland
Affected count
26
Manufactured in
2005 E State St Ste 100, N/A, Athens, OH, United States
Products
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2018Don't want to check this manually?
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