Quebec® Digital Darkfield Colony Counter
Catalogue number 13332700, listed by Reichert Inc., United States, under Automated Colony Counter. 3 manufacturers in China are registered for this product code.
Automated Colony Counter
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Shandong and Shanghai: 3 hold an FDA registration.
- Infitek Co., Ltd. Shanghai
- Labpeak Co., Ltd. Shandong
- Scitek Global Co., Ltd. Shandong
What Is FDA Product Code KZB?
Automated Colony Counter is FDA product code KZB, Class 1, 21 CFR 866.2170.
How Does It Reach the US Market?
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.
What Do the Recalls Say?
The FDA has recorded 2 recalls under this product code since 2024. None was by a company in China. The root cause the FDA records most often is No Marketing Application (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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