Quantech, Ltd.
Country not established
- Devices
- 3
What Quantech, Ltd. makes
Quantech, Ltd. manufactures in vitro diagnostic (IVD) assays and automated analyzer systems for clinical laboratory use, including the QUANTECH Total β-hCG Assay for pregnancy testing, the QUANTECH CK-MB Assay for cardiac marker detection, and the QUANTECH FastRaQ automated analyzer with compatible test cartridges like the PrePaQ Total HCG.
These devices are regulated as Class II under the FDA’s 510(k) clearance pathway and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Quantech Total B-Hcg Assay Ref K990258
Regimes: 510(k) Registry: 510(k)Quantech Ck-Mb Assay Ref K984433
Regimes: 510(k) Registry: 510(k)The Quantech Fastraq Automated Analyzer, And The Quantech Prepaq Total Hcg Test Cartridge Ref K012943
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Quantech, Ltd. have in the registry?
The registry currently lists 3 devices for Quantech, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quantech, Ltd.'s devices?
Among its 3 most recently registered devices, Quantech, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Quantech, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Quantech, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Quantech, Ltd. in the registry?
The most recently registered devices listed for Quantech, Ltd. include QUANTECH TOTAL B-HCG ASSAY, QUANTECH CK-MB ASSAY and THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE.