Saudi Arabia SFDA registration ME0000001030SFDAA00230
Chla/Myco Pneumo r-gene®
Product information
Genic Detection Kit
Product use
Chlamydophila pneumoniae and Mycoplasma pneumoniae are bacteria frequently found among pathogenic agents responsible for atypical pneumopathies. They represent a high proportion (from 25 to 50%) of pneumopathies listed, even in hospitals. Our Chla/Myco pneumo r-gene™ kit is a duplex detection of both Chlamydophila pneumoniae and Mycoplasma pneumoniae. This product relies on the 5’ nuclease Real-Time PCR technology and thus utilizes its sensitivity and specificity. Chla/Myco pneumo r-gene™ belongs to the Respiratory MWS r-gene™ range of real-time PCR products for the detection of infectious agents (RSV, hMPV, Influenza A, Influenza B, Rhinovirus, Enterovirus, Adenovirus, Bocavirus, Coronavirus, Parainfluenza, ...). Each kit is a duplex PCR designed to detect specific targets from the same extracted sample, with a protocol and an amplification program that are common to all the Respiratory MWS r-gene™ products. Our kit, Chla/Myco pneumo r-gene™, is user-friendly as it offers ready-to-use reagents. All your results will be validated with the positive and negative controls provided in the kit. A cellular control will also validate the sample quality and the whole process, from extraction to amplification. The detection of this cell control is possible when using simultaneously our kit Rhino&EV/Cc r-gene™ (ref. : 71-042) or our CELL control r-gene™ (ref. : 71-106.. The major extraction and amplification platforms have been validated with all the products of the Respiratory MWS r-gene™ range. Methods for DNA amplification using Polymerase Chain Reaction (PCR), RT-PCR process and 5’ nuclease are covered by US patents issued to Hoffman-La Roche. Neither anything in this publication nor purchase of this product from Argene should be construed as an authorization or implicit license to use these methods.
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001030SFDAA00230
- Authorization ID
- GHTF-2014-0146
- Status
- Active
- Expire Date
- November 07, 2016
Manufacturer
- Manufacturer Name
- BIOMERIEUX S.A.
Model information
- Model ID(s)
- 71-044
Product accessories
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About this record
Access comprehensive regulatory information for Chla/Myco Pneumo r-gene® in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List B device is registered with Saudi Arabia SFDA under registration number ME0000001030SFDAA00230 and manufactured by BIOMERIEUX S.A..
This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
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