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AMYLASE (CNPG3) Reagent Set
CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Model 4 x 120 mL · UDI-DI 00812137011879
10
510(k) clearances
1
Adverse events
1
Recalls
6
Facilities
Description
For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.
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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