Microscope, Inverted Stage, Tissue Culture
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Jiangsu, Fujian and Shanghai, and 1 other province: 7 hold an FDA registration. 2 are contract manufacturers.
- Citotest Labware Manufacturing Co., Ltd. Jiangsu
- Citotest Scientific Co., Ltd. Jiangsu
- Carl Zeiss Suzhou Co., Ltd. Jiangsu
- Leica Instruments (Shanghai) Co., Ltd. Shanghai, contract manufacturer
- Motic China Group Co Ltd Fujian, contract manufacturer
- Nanjing Nikon Jiangnan Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
- Ningbo Haishu District Proway IMP. & EXP. Co., Ltd. Zhejiang
How Is IBL Classified?
Microscope, Inverted Stage, Tissue Culture is FDA product code IBL, Class 1, 21 CFR 864.3600.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
Name
Record