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"Omon immunofluorescence" anti-epidermal spinous cell desmosomes antibody/anti-epidermal basement membrane antibody reagent - Taiwan Registration f8f016261e77844cb31c15eac5135ad5

Access comprehensive regulatory information for "Omon immunofluorescence" anti-epidermal spinous cell desmosomes antibody/anti-epidermal basement membrane antibody reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f8f016261e77844cb31c15eac5135ad5 and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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f8f016261e77844cb31c15eac5135ad5
Registration Details
Taiwan FDA Registration: f8f016261e77844cb31c15eac5135ad5
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Device Details

"Omon immunofluorescence" anti-epidermal spinous cell desmosomes antibody/anti-epidermal basement membrane antibody reagent
TW: โ€œๆญ่’™โ€ๅ…็–ซ่žขๅ…‰ๆณ•ๆŠ—่กจ็šฎๆฃ˜็ดฐ่ƒžๆฉ‹็ฒ’ๆŠ—้ซ”/ๆŠ—่กจ็šฎๅŸบๅบ•่†œๆŠ—้ซ”่ฉฆๅŠ‘
Risk Class 2

Registration Details

f8f016261e77844cb31c15eac5135ad5

DHA05603242105

Product Details

This product is used for the in vitro qualitative or semi-quantitative detection of anti-spinous desmosomes and epidermal basement membrane antibody immunoglobulin G (IgG) in patient samples to assist in the diagnosis of autoimmune bullous skin diseases.

C Immunology and microbiology

C.5660 ๅคš็™ผๆ€ง่‡ช้ซ”ๆŠ—้ซ”ๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

May 06, 2019

May 06, 2029