Taiwan FDA registration 88caaa598c0ef8855544ea553b4b7ccb

Cimosir lupus anticoagulant factor analysis reagent

TW: 希摩西爾狼瘡性抗凝血因子分析試劑

Taiwan·Risk Class 2·INSTRUMENTATION LABORATORY CO.·Registered Oct 23, 2012 – Oct 23, 2027Active

Registration details

Analysis ID: 88caaa598c0ef8855544ea553b4b7ccb
Customs Code: DHA00602409901

Company information

Manufacturer: INSTRUMENTATION LABORATORY CO.
Manufacturer Country: United States
Authorized Representative: Werfen Taiwan Limited

Product details

Intended Use: HemosIL dRVVT Screen and dRVVT Confirm are qualitative in vitro diagnostic reagents used by diluted Russell's Viper Venom method in IL coagulation system ACL TOP, ACL TOP 500 CTS, ACL ELITE/ELITE PRO 8/9/10000, ACL Advance, ACL Classic ( 100-7000) to analyze lupus anticoagulant factor in citrate acidified human plasma to assess patients for unexplained prolonged APTT.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.8950 Snake venom reactive agent for Lessell's vipers
Import Information: import

Dates and status

Registration Date: Oct 23, 2012
Expiry Date: Oct 23, 2027

About this record

Access comprehensive regulatory information for Cimosir lupus anticoagulant factor analysis reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 88caaa598c0ef8855544ea553b4b7ccb and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.

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