South Korea MFDS registration In Vitro Reception No. 19-2127
Clinical Examination Universal Quality Control Substance I.
KO: 임상검사범용정도관리물질Ⅰ
South Korea·Class I·Dong Aesti Co., Ltd.·Approved Aug 26, 2019Basic information
- Item Serial Number
- 2019005301
- License Number
- In Vitro Reception No. 19-2127
- Classification Number
- J08060.01(1)
- Device Class (Risk Classification)
- Class I
- Classification Name
- Clinical Examination Universal Quality Control Substance I.
- Official English Name
- General calibrators, controls or standards, classⅠ, for clinical chemistry
체외수신19-2127호
임상검사범용정도관리물질Ⅰ
Company information
- Entity Address
- 서울특별시 동대문구 천호대로 64 (용두동)
- Manufacturer
- More Diagnostics Inc.
- Category
- Import business
- Business License Number
- 체외 제 561 호
수입업
Important dates & status
- Item Approval Date
- Aug 26, 2019
- Business Permit Date
- May 16, 2005
- Expiration Period
- 2020-10-08 ~ 2030-09-30
- For Export
- 아니오
Model information
- Model Name
- DongA MORE Diagnostics Rap/Tac/CsA Control, Level 1외 2건
About this record
This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Reception No. 19-2127. Approved on Aug 26, 2019. Registered by Dong Aesti Co., Ltd..
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