Genzyme Diagnostics P.E.I., Inc.
CanadaFDA applicant, unverified
- Devices
- 2
What Genzyme Diagnostics P.E.I., Inc. makes
Genzyme Diagnostics P.E.I., Inc. manufactures in-vitro diagnostic reagents for laboratory testing, including acetaminophen assays (Models 506-10 and 506-30) and total bilirubin assays (Models 295-10 and 295-30). These products are designed for quantitative measurement in clinical chemistry analyzers.
The company’s diagnostic reagents are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Total Bilirubin L3K, Model 295-10 And 295-30 Ref K082210
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genzyme Diagnostics P.E.I., Inc. have in the registry?
The registry currently lists 2 devices for Genzyme Diagnostics P.E.I., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genzyme Diagnostics P.E.I., Inc.'s devices?
Among its 2 most recently registered devices, Genzyme Diagnostics P.E.I., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Genzyme Diagnostics P.E.I., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Genzyme Diagnostics P.E.I., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genzyme Diagnostics P.E.I., Inc. in the registry?
The most recently registered devices listed for Genzyme Diagnostics P.E.I., Inc. include ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 and TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30.