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Pointe Amylase Reagent
HORIBA INSTRUMENTS INCORPORATED · Model 16-HA965-223 · UDI-DI 00811727016034
CIJ
Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
6
Facilities
Description
Pointe Amylase Reagent packaged for use on the Mindray BA800. 3 x 63ml R1, 2 x 17ml R2. For the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-07-10 | RANDOX LABORATORIES, LTD. | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. |
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