Question 1

How many devices does Shenzhen Biorain biotechnology Co., Ltd. have in the registry?

Accepted Answer

The registry currently lists 9 devices for Shenzhen Biorain biotechnology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Question 2

Which registries list Shenzhen Biorain biotechnology Co., Ltd.'s devices?

Accepted Answer

Among its 9 most recently registered devices, Shenzhen Biorain biotechnology Co., Ltd. has devices listed in EUDAMED (9 devices).

Question 3

What risk classes do Shenzhen Biorain biotechnology Co., Ltd.'s devices fall under?

Accepted Answer

Among its 9 most recently registered devices, the classes recorded for Shenzhen Biorain biotechnology Co., Ltd.'s devices are IVD general. Each device page shows its own class and authorisation.

Question 4

What are the newest devices from Shenzhen Biorain biotechnology Co., Ltd. in the registry?

Accepted Answer

The most recently registered devices listed for Shenzhen Biorain biotechnology Co., Ltd. include Human HER2 Gene copy number variation Detection Kit (Digital PCR Method), Human BRAF Gene V600E Mutation Detection Kit (Digital PCR Method), Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method) and Human BCR-ABL(P210) Fusion Gene Detection Kit (Digital PCR Method).

Shenzhen Biorain biotechnology Co., Ltd.

Catalogue9

Human HER2 Gene copy number variation Detection Kit (Digital PCR Method) Ref R34008-048

Human BRAF Gene V600E Mutation Detection Kit (Digital PCR Method) Ref R34010-048

Human BRAF Gene V600E Mutation Detection Kit (Digital PCR Method) Ref R34010-096

Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method) Ref R33001-096

Human HER2 Gene copy number variation Detection Kit (Digital PCR Method) Ref R34008-096

Human BCR-ABL(P210) Fusion Gene Detection Kit (Digital PCR Method) Ref R34001-048

Human BCR-ABL(P210) Fusion Gene Detection Kit (Digital PCR Method) Ref R34001-096

Human AML1-ETO Fusion Gene Detection Kit (Digital PCR Method) Ref R34004-048

Human BCR-ABL(P190) Fusion Gene Detection Kit (Digital PCR Method) Ref R34002-096

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