Legacy registrant archive

Xiamen Innodx BIOTECH Co., Ltd.

厦门万泰凯瑞生物技术有限公司

FujianChina NMPA183 archived records

Static archiveNMPA · legacy registration snapshot

183

Archived records

2

Device classes

2017

Earliest approval

2025

Latest approval

Company overview

Archived records: 183
Province/Region: Fujian
Address: 2nd floor, No. 124, Xinyuan Road, Xinyang Street

Registration timeline

Earliest approval: Jun 28, 2017
Latest approval: Jan 20, 2025

Regulatory footprint

Search Xiamen Innodx BIOTECH Co., Ltd. across other regulatory registries

Device class distribution

Breakdown of 183 devices by regulatory classification

Class II9652.5% of total

Class III8747.5% of total

Archived records (10 most recent shown)

Click on any device for detailed registration information

Herpes simplex virus type 1 IgG antibody test kit (magnetic particle chemiluminescence method)

单纯疱疹病毒1型IgG抗体检测试剂盒（磁微粒化学发光法）

Registration number: 国械注准20253400211
Class: Class III
Expiry date: Jan 19, 2030

Herpes Simplex Virus Type 2 IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)

单纯疱疹病毒2型IgM抗体检测试剂盒（磁微粒化学发光法）

Registration number: 国械注准20253400089
Class: Class III
Expiry date: Jan 09, 2030

Cytomegalovirus IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)

巨细胞病毒IgM抗体检测试剂盒（磁微粒化学发光法）

Registration number: 国械注准20253400077
Class: Class III
Expiry date: Jan 09, 2030

Herpes simplex virus type 1 IgM antibody detection test kit (magnetic particle chemiluminescence method)

单纯疱疹病毒1型IgM抗体检测试剂盒（磁微粒化学发光法）

Registration number: 国械注准20253400103
Class: Class III
Expiry date: Jan 09, 2030

EB病毒BNLF2b抗体检测试剂盒(磁微粒化学发光法)

EB病毒BNLF2b抗体检测试剂盒（磁微粒化学发光法）

Registration number: 国械注准20243402134
Class: Class III
Expiry date: Oct 23, 2029

Rubella Virus IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)

风疹病毒IgM抗体检测试剂盒（磁微粒化学发光法）

Registration number: 国械注准20243401942
Class: Class III
Expiry date: Sep 28, 2029

Total thyroxine (TT4) Assay Kit (Magnetic Particle Chemiluminescence Method)

总甲状腺素(TT4)测定试剂盒（磁微粒化学发光法）

Registration number: 闽械注准20242400173
Class: Class II
Expiry date: Sep 19, 2029

Free thyroxine (FT4) detection reagent kit (magnetic particle chemiluminescence method)

游离甲状腺素(FT4)测定试剂盒（磁微粒化学发光法）

Registration number: 闽械注准20242400174
Class: Class II
Expiry date: Sep 19, 2029

Cytomegalovirus IgG antibody test kit (magnetic microparticle chemiluminescence method)

巨细胞病毒IgG抗体检测试剂盒（磁微粒化学发光法）

Registration number: 国械注准20243401663
Class: Class III
Expiry date: Sep 01, 2029

Rubella Virus IgG Antibody Assay Kit (Magnetic Particle Chemiluminescence Method)

风疹病毒IgG抗体测定试剂盒（磁微粒化学发光法）

Registration number: 国械注准20243401310
Class: Class III
Expiry date: Jul 22, 2029

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About this profile

This static archive contains 183 records under the historical name Xiamen Innodx BIOTECH Co., Ltd.. It does not establish the company's complete current portfolio or current authorization status.

Historical English translations and official Chinese names can differ. These archived names are not automatically equated with a holder in the current domestic-registration listing.