PCN
2018-02-15
Immunoglobulin G Kappa Heavy And Light Chain Combined
FDA product code PCN · 3 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.5510
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 2013-12-20 – 2018-02-15
Intended for the in-vitro quantification of IgG kappa concentration in human serum.
PCN
2016-10-04
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
View details →
PCN
2013-12-20
HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
View details →No matching devices.
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