Vietnam MOH registration 2403386ĐKLH/BYT-HTTB

Interleukin-6 (IL-6) Quantitative Testing Reagent

VN: Thuốc thử xét nghiệm định lượng Interleukin‑6 (IL‑6)
Vietnam flagVietnam·Risk Class TTBYT Loại C·Elecsys IL-6·Roche Diagnostics GmbH·Registered Nov 06, 2024
Registration details
Analysis ID
2403386ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230327-0014
Product Type
Elecsys IL-6
Product Code
09015612190
Company information
Manufacturer Country
GERMANY
Authorized Representative
CÔNG TY TNHH ROCHE VIỆT NAM
Technical details
Intended Use
Elecsys IL-6 is an in vitro immunoassay used to quantify Interleukin-6 (IL-6) in human serum and plasma. The test is used in conjunction with clinical evaluation to support: ▪ the management of severely ill patients as an early indicator of acute inflammation ▪ the diagnosis of sepsis in suspected or confirmed cases of sepsis in infants The "ECLIA" (electrochemiluminescence immunoassay "ECLIA") fluorescent immunoassay is used in the cobas e. immunoassay system.
Dates and status
Registration Date
Nov 06, 2024
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About this record

Access comprehensive regulatory information for Interleukin-6 (IL-6) Quantitative Testing Reagent in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403386ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Roche Diagnostics GmbH, and 1 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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