GENETIC TESTS - OTHER

Primary DI

06937044500903

Basic UDI-DI Code

B-06937044500903

Reference

1040007

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ningbo HEALTH Gene Technologies Co., LTD.

The SureID® Compass Human DNA Identification Kit(Direct) offer a 34-loci multiplex assay for the applications of human DNA identification including forensic analysis, family relationship testing and research use. The 6-dye system can simultaneously amplify 15 autosomal STR loci and one sex determining marker, Amelogenin in addition with 17 Y-STR loci plus one insertion/deletion polymorphic marker on the Y chromosome (Y-indel). This feature is especially efficient for suspect screening in sexually assaulting cases. Formulated with high performance master mix, the kits offer high sensitivity and great tolerance to various inhibitors.The Polymerase Chain Reaction (PCR) process is employed for DNA amplification while detection of the PCR product is accomplished ABI PRISM® instruments following the protocols in the SureID® Compass Human DNA Identification Kit(Direct) User’s Manual. Genotypes can be assigned to samples by comparison of sample alleles to the known alleles contained in the SureID® Compass Allelic Ladder Mix.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).