Natural Kidney Medicine,Vitamin C Minoxidil,Dinoprostone Api Powder,Yohimbine Hcl Powder Xi'an Henrikang Biotech Co.,Ltd , https://www.henrikangbio.com
May 31, 2011 Medical Device Import Approval Notice
Business Club News, June 3
No.
Acceptance number
Variety name
applicant
Note
1
Jin 08-2135
Lactate dehydrogenase assay kit (colorimetric method)
Beckman Coulter, Inc. Beckman Coulter, Inc.
2
Into 08-4023
Rheumatoid factor assay kit (immune turbidimetry)
Siemens Healthcare Diagnostics Inc.
3
Into 09-2170
Amylase assay kit
Prodia Diagnostics
4
Into 09-2172
Calcium assay kit
Prodia Diagnostics
5
Into 09-2173
Phosphorus assay kit
Prodia Diagnostics
6
Into 09-2174
Total protein assay kit
Prodia Diagnostics
7
Into 09-2175
Potassium assay kit
Prodia Diagnostics
8
Into 09-2176
Lipoprotein (a) assay kit
Prodia Diagnostics
9
Into 09-2178
Zinc assay kit
Prodia Diagnostics
10
Into 09-2180
Iron assay kit
Prodia Diagnostics
11
Into 09-2181
Chlorine assay kit
Prodia Diagnostics
12
Into 09-2182
Creatinine determination kit
Prodia Diagnostics
13
Into 09-2183
Total bile acid assay kit
Prodia Diagnostics
14
Into 09-2184
Low density lipoprotein cholesterol assay kit
Prodia Diagnostics
15
Into 09-2185
Albumin assay kit
Prodia Diagnostics
16
Into 09-2186
Total iron binding assay kit
Prodia Diagnostics
17
Into 09-2187
Magnesium assay kit
Prodia Diagnostics
18
Into 09-2189
High-density lipoprotein cholesterol assay kit
Prodia Diagnostics
19
Into 09-2190
Apolipoprotein B assay kit
Prodia Diagnostics
20
Into 09-2191
Apolipoprotein A1 Assay Kit
Prodia Diagnostics
twenty one
09-2915.1
Blood glucose test strip
Infopia Co.,Ltd
twenty two
09-2915.2
Blood glucose test strip
Infopia Co.,Ltd
twenty three
In 09-2915.3
Blood glucose test strip
Infopia Co.,Ltd
twenty four
10-1024
Leukocyte Differentiation Antigen CD38 Detection Kit (Flow Cytometry)
France IMMUNOTECH SAS (a Beckman Coulter Company)
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
25
Into 10-1025
Leukocyte Differentiation Antigen CD45RO Detection Kit (Flow Cytometry)
France IMMUNOTECH SAS (a Beckman Coulter Company)
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
26
Into 10-1278
Total triiodothyronine assay kit (heterogeneous immunoassay)
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
27
Into 10-1279
Thyroxine Binding Rate Assay Kit (Heterogeneous Immunoassay)
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
28
Into 10-1281
Thyroxine Assay Kit (Heterogeneous Immunoassay)
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
29
Into 10-1282
Ferritin Assay Kit (Heterogeneous Immunoassay)
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
30
Into 10-1937
Thyroid stimulating hormone assay kit (heterogeneous immunoassay)
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
31
Into 10-1948
Multiple protein calibrators
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
32
10-2522
Ferritin test sample diluent
Tosoh Corporation
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
33
Into 10-3186
Free Subunit Determination Kit (Time-Resolved Fluorometry)
Wallac Oy
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
34
Into 10-3192
Free estriol assay kit (time resolved fluorescence method)
Wallac Oy
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
35
Into 10-3193
Pregnancy Associated Plasma Protein A Assay Kit (Time-Resolved Fluorometry)
Wallac Oy
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
36
Into 10-3883
Leukocyte Differentiation Antigen CD11b Assay Kit (Flow Cytometry-PE)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
37
Into 10-3884
Leukocyte Differentiation Antigen CD2 Detection Kit (Flow Cytometry - APC)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
38
Into 10-3885
Leukocyte Differentiation Antigen CD38 Detection Kit (Flow Cytometry-FITC)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
39
Into 10-3886
Leukocyte Differentiation Antigen CD8 Detection Kit (Flow Cytometry-PE-Cy7)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
40
Into 10-3887
Leukocyte Differentiation Antigen CD19 Detection Kit (Flow Cytometry-FITC)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
41
Into 10-3888
Leukocyte Differentiation Antigen CD33 Detection Kit (Flow Cytometry - PE-Cy7)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
42
Into 10-3889
Leukocyte Differentiation Antigen CD5 Detection Kit (Flow Cytometry - PerCP-Cy5.5)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
43
Into 10-3891
Leukocyte Differentiation Antigen CD16 Detection Kit (Flow Cytometry-FITC)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
44
Into 10-3892
Leukocyte Differentiation Antigen CD19 Detection Kit (Flow Cytometry-PE-Cy7)
Becton, Dickinson and Company, BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
45
Into 10-3985
Gram-negative bacterial identification/drug sensitivity plate
Becton, Dickinson and Company
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.