Taiwan FDA registration 9b1aac534321e72ed14c5d6986346a0a

Pre-assay calcitonin test reagent for Roche immunoassay.

TW: 羅氏免疫分析前降鈣素檢驗試劑。

Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Feb 27, 2009 – Feb 27, 2029Active

Registration details

Analysis ID: 9b1aac534321e72ed14c5d6986346a0a
Customs Code: DHA00601995405

Company information

Manufacturer: ROCHE DIAGNOSTICS GMBH
Manufacturer Country: Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: This product uses electrochemiluminescence immunoassay (ECLIA) with Elecsys 2010, cobas e 411, MODULAR ANALYTICS E170, coabs e 601, and cobas e 602 immunoassays to quantitatively detect procalcitonin (PCT) in human serum and plasma in vitro. This product (specification: 07301715190) uses electrochemiluminescence immunoassay (ECLIA) with cobas e 801 immunoassay to quantitatively detect procalcitonin (PCT) in human serum and plasma in vitro. This product (08828644190) uses electrochemiluminescence immunoassay (ECLIA) with cobas e 411, coabs e 601, and cobas e 602 immunoassays for the quantitative detection of procalcitonin (PCT) in human serum and plasma in vitro. This product (08828679190) uses electrochemiluminescence immunoassay (ECLIA) with cobas e 801 immunoassay to quantitatively detect procalcitonin (PCT) in human serum and plasma in vitro. The following blank models 08828679190 change the efficacy (new applicable models) are: This product uses electrochemiluminescence immunoassay (ECLIA) with cobas e 402 and cobas e 801 immunoassay to quantitatively detect procalcitonin (PCT) in human serum and plasma in vitro. The following blanks
Product Type (Level 1): C Immunology and microbiology
Import Information: import

Dates and status

Registration Date: Feb 27, 2009
Expiry Date: Feb 27, 2029

About this record

Access comprehensive regulatory information for Pre-assay calcitonin test reagent for Roche immunoassay. in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9b1aac534321e72ed14c5d6986346a0a and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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