The Food and Drug Administration announced that it has withdrawn 130 applications from 44 medical machinery enterprises (with attached form)

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On October 26, the Food and Drug Administration announced that 44 companies had withdrawn their 130 medical device registration application projects. The announcement showed that from August 26, 2016 to October 19, 2016, a total of 44 companies withdrew 130 medical treatments. Device registration application. Among them, the State Food and Drug Administration's "Notice on the Relevant Situations of Clinical Trial Supervision and Spot Checking of Four Medical Device Registration Applications" (No. 147 of 2016) has withdrawn 13 enterprises (see Annex 1); in Liaoning Province The registration application for medical device clinical trials by the Three People's Hospital, the Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine and the Third People's Hospital of Jilin Province has been withdrawn by 85 (see Annex 2); other applications for medical device registration have been withdrawn by themselves 32 (See Annex 3), the specific list is as follows:

attachment1:

Serial number

Acceptance number

product name

applicant

1

CSX1600004

Alpha-fetoprotein assay kit (chemiluminescence method)

Sichuan Mike Biotechnology Co., Ltd.

2

CSZ1600047

Schistosomiasis Antibody Detection Kit (Colloidal Gold Method)

Sichuan Mike Biotechnology Co., Ltd.

3

CSZ1600165

ABO , RhD blood type test card (microcolumn gel method)

Sichuan Mike Biotechnology Co., Ltd.

4

CSX1600002

Hepatitis C virus antibody assay kit

(Chemiluminescence method)

Sichuan Mike Biotechnology Co., Ltd.

5

CSZ1600166

Anti-human globulin (anti- IgG + C3d ) test card

(microcolumn gel method)

Sichuan Mike Biotechnology Co., Ltd.

6

Standard 15-2796

Hepatitis B virus e antigen calibrator

(Chemiluminescence method)

Sichuan Mike Biotechnology Co., Ltd.

7

Standard 15-2795

Hepatitis B virus e antigen control

(Chemiluminescence method)

Sichuan Mike Biotechnology Co., Ltd.

8

Enter   15-1886

Rheumatoid factor IgA antibody assay kit

(enzyme immunoassay)

ORGENTEC Diagnostika GmbH

9

Enter   15-1889

Rheumatoid factor antibody screening kit

(law)

ORGENTEC Diagnostika GmbH

10

Enter   15-1884

Anti-centromere B antibody assay kit (enzyme immunoassay)

ORGENTEC Diagnostika GmbH

11

Enter   15-1885

Rheumatoid factor IgG antibody assay kit

(enzyme immunoassay)

ORGENTEC Diagnostika GmbH

12

Enter   15-1681

Anti-cyclic citrullinated peptide antibody assay kit

(law)

ORGENTEC Diagnostika GmbH

13

Enter   15-1683

Anti-cyclic citrullinated peptide antibody assay kit

(enzyme immunoassay)

ORGENTEC Diagnostika GmbH

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