Taiwan FDA registration 2425a9c773ad8866ede9cf22e706167b

"GENBIO" MYCOPLASMA PNEUMONIAE ANTIBODY TEST Reagent (Non-sterile)

TW: "吉利拜歐" 黴漿菌抗體檢測試劑(未滅菌)

Taiwan·Risk Class 1·MD·INNOMINATA DBA GENBIO·Registered Aug 19, 2022 – Aug 19, 2027Active

Registration details

Analysis ID: 2425a9c773ad8866ede9cf22e706167b
License Form: Ministry of Health Medical Device Import No. 022879
Customs Code: DHA09402287901

Company information

Manufacturer: INNOMINATA DBA GENBIO
Manufacturer Country: United States
Authorized Representative: TRUGENE DIAGNOSTICS, INC.

Product details

Intended Use: Limited to the classification and grading management method of medical equipment, the first level identification range of "Mycoplasma serum reagent (C.3375)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C3375 Mycoplasma serum reagent
Import Information: Imported from abroad; GMP

Dates and status

Registration Date: Aug 19, 2022
Expiry Date: Aug 19, 2027

About this record

Access comprehensive regulatory information for "GENBIO" MYCOPLASMA PNEUMONIAE ANTIBODY TEST Reagent (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2425a9c773ad8866ede9cf22e706167b and manufactured by INNOMINATA DBA GENBIO. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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