Genzyme Diagnostics
Country not established
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Genzyme Diagnostics makes
Genzyme Diagnostics manufactures rapid diagnostic tests for pregnancy and infectious diseases, including urine and serum human chorionic gonadotropin (hCG) assays, as well as combo rapid assays for *Giardia* and *Cryptosporidium*. Their product line also includes contrast strips and standalone hCG tests for both urine and serum applications.
All listed devices fall under Class II regulatory classification in the US, with authorisation via FDA 510(k) clearance. The company is based in the United States and its products are registered under the FDA’s regulatory framework.
Catalogue
Contrast Strip Hcg Ref K964156
510(k) 510(k)Osom Hcg Combo Test Ref K043385
510(k) 510(k)Giardia/Cryptosporidium Combo Rapid Assay Ref K983399
510(k) 510(k)- 510(k) 510(k)
Genzyme Diagnostics Contrast Mono Ref K963425
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Genzyme Diagnostics, initiated on 2004-02-23. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 23 Feb 2004 Z-0770-04 Unclassified (pre-2012) Terminated False Positive results.
Full distribution text
- 23 Feb 2004 Z-0770-04 Unclassified (pre-2012) Terminated False Positive results.
Frequently asked questions
How many devices does Genzyme Diagnostics have in the registry?
The registry currently lists 5 devices for Genzyme Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genzyme Diagnostics's devices?
Among its 5 most recently registered devices, Genzyme Diagnostics has devices listed in FDA 510(k) (5 devices).
What risk classes do Genzyme Diagnostics's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Genzyme Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Genzyme Diagnostics?
FDA recall records list 1 recall initiated by Genzyme Diagnostics, the most recent initiated on 2004-02-23. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Genzyme Diagnostics in the registry?
The most recently registered devices listed for Genzyme Diagnostics include CONTRAST STRIP HCG, OSOM HCG COMBO TEST, GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY and CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST.