Home › DRG International Inc › Galactose (with Membrane Plate) ELISA
Galactose (with Membrane Plate) ELISA
DRG International Inc · Model EIA-1488 · UDI-DI 00840239014887
JIA
Prescription
9
510(k) clearances
0
Adverse events
6
Recalls
2
Facilities
Description
The DRG neonatal Galactose ELISA is designed for the quantitative determination of galactose in neonatal blood spots. It is for in vitro diagnostic use as an aid in screening newborns for elevated galactose levels as seen in galactosemia.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-09-08 | PerkinElmer LAS Inc | There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the spec |
| 2004-01-09 | Perkin Elmer Life and Analytical Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2004-01-09 | Perkin Elmer Life and Analytical Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
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