Thermocycler, Generic
Clinical Chemistry · 21 CFR 862.2310
A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps, based on the specifications of the test which is being run. It may integrate interchangeable blocks of different materials or to accommodate different well and tube formats.
Recent MDR events
6 adverse event reports on file
- C1000 (TOUCH) THERMAL CYCLER CHASSISJul 18, 2016MalfunctionBio-radMW5063473
- S1000 AND C1000 (TOUCH) THERMAL CYCLER CHASSISJul 18, 2016MalfunctionBio-radMW5063494
- S1000 THERMAL CYCLER CHASSISJul 18, 2016MalfunctionBio-radMW5063495
- S1000 THERMAL CYCLER CHASSISJul 18, 2016MalfunctionBio-radMW5063496
- VERTI DX THERMAL CYCLERMay 2, 2014MalfunctionLife Technologies Holdings Pte. Ltd.3003673482-2014-00010
- VERITI DX THERMAL CYCLERApr 21, 2014MalfunctionLife Technologies Holdings Pte. Ltd.3003673482-2014-00008
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
Life Technologies Holdings Pte Ltd.
SINGAPORE North West, SG
Hangzhou Bioer Technology Co., Ltd
Hangzhou Zhejiang, CN
Bioptic Inc.
New Taipei, TW
Guangzhou Four E's Scientific Co., Ltd.
GUANGZHOU Guangdong, CN
Citotest Scientific Co.,ltd.
Nanjing Jiangsu, CN
Citotest Labware Manufacturing Co., Ltd.
Haimen Jiangsu, CN
Infitek Co., Ltd.
Shanghai, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.