Genzyme Direct-Amylase Test Reagent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011843 FDA 510(k)
- FDA Product Code
- JFJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1070 FDA 510(k)
- Regulation Number
- 862.1070 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Genzyme Direct-Amylase Test Reagent is a Class II medical device classified under Catalytic Methods, Amylase. It is designed for the quantitative determination of amylase activity in human serum and plasma using catalytic methods.
This reagent is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code JFJ. It is manufactured by Genzyme Corp. in Cambridge, MA, and is intended for use in clinical chemistry laboratories for diagnostic testing purposes.
Frequently asked questions
What is the Genzyme Direct-Amylase Test Reagent used for?
The Genzyme Direct-Amylase Test Reagent is designed for the quantitative determination of amylase activity in human serum and plasma using catalytic methods. It is intended for use in clinical chemistry laboratories for diagnostic testing purposes.
How is the Genzyme Direct-Amylase Test Reagent supplied?
The reagent is supplied as a single-use product. It is manufactured by Genzyme Corp. in Cambridge, MA, and is intended for use in clinical chemistry laboratories for diagnostic testing purposes.
What is the regulatory status of the Genzyme Direct-Amylase Test Reagent?
The Genzyme Direct-Amylase Test Reagent is a Class II medical device classified under Catalytic Methods, Amylase. It is regulated under FDA 510(k) clearance with product code JFJ and was found to be substantially equivalent to predicate devices.
What are the specifications of the Genzyme Direct-Amylase Test Reagent?
The reagent is designed for quantitative determination of amylase activity in human serum and plasma using catalytic methods. It is a single-use product manufactured by Genzyme Corp. in Cambridge, MA, with FDA 510(k) clearance and product code JFJ.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K921057 FDA 510 (k) - AMYLASE REAGENT | Genzyme Corp., Genzyme Direct-amylase Test Reagent 510 (k) FDA Premarket Notification ..., K933397 FDA 510 (k) - GENZYME A-AMYLASE TEST REAGENT, Genzyme Direct-amylase Test Reagent 510 (k) FDA Premarket Notification ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011843 | Class II | Active |
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Manufacturer
- Manufacturer
- Genzyme Corp.
Sources (1)
- FDA 510(k) K011843 24 fields · synced Sep 27, 2026