IVDR controls
In vitro diagnostic reagent
Number |
Name |
Test principle/application |
Specification |
GBDS-BCY-001 |
Sample preservation solution (YSXB No. 20160299)
|
Inactivation principle: Guanidine salt can denature proteins, dissolve proteins and make proteins the cytoplasmic secondary structure disappears, resulting in cell structure degradation and rapid separation of nucleoprotein from nucleic acid away. Protein denaturation can be used to inactivate freshly collected clinical samples use, greatly reduce the sampling process of medical personnel, sample transport process, inspection process the risk of biological transmission in The clinical sample was completely immersed in the preservation solution for 5 minutes, to inactivate viruses/other microorganisms in the sample. Stability principle: Guanidine salt not only has the function of precipitation protein, but also has inhibit the action of nuclease, so as to ensure that the released nucleic acid is not degraded. into split nucleic acid protectors can be very good for nucleic acids, especially single-stranded RNA to the protective effect that allows the RNA to be preserved. For those who cannot be detected in time bed samples or samples that need to be transported long distances play a very good protective role in preventing Stop the degradation of viral nucleic acid in the sample. |
1 mL/tube, 100 tubes/kit |
GBDS-BCY-002 |
2 mL/tube, 100 tubes/kit |
||
GBDS-BCY-005 |
3 mL/tube, 100 tubes/kit |
||
GBDS-BCY-004 |
6 mL/tube, 50 tubes/kit |
||
GBDS-BCY-003 |
6 mL tube, 128tubes/kit |
||
GBDS-BCY-006 |
40 mL/tube/ bag |
||
GBDS-BCY-012 |
40 mL/tube, 5 tube/bag |
||
GBDS-BCY-013 |
200 mL/bottle/bag |
||
GBDS-BCY-007 |
500 mL/bottle/bag |
||
GBDS-BCY-011 |
Sample preservation solution (YSXB No. 20160298)
|
Stability principle: The main component has the effect of inhibiting nuclease, thus protecting the released nucleic acid is not degraded. Clinical markers that cannot be detected in time. This or the need for long-distance transportation of specimens to play a good protective role, can prevent labeling degradation of viral nucleic acids in the virus.
|
1 mL/tube, 100 tubes/kit |
GBDS-BCY-014 |
2 mL/tube, 100 tubes/kit |
||
GBDS-BCY-015 |
3 mL/tube, 100 tubes/kit |
||
GBDS-BCY-016 |
6 mL/tube, 50 tubes/kit |
||
GBDS-BCY-017 |
6 mL/tube, 128 tubes/kit |
||
GBDS-BCY-018 |
400 mL/tube/ bag |
||
GBDS-BCY-019 |
40 mL/tube, 5 tubes/bag |
||
GBDS-BCY-020 |
200 mL/bottle/ bag |
||
GBDS-BCY-021 |
500 mL/bottle bag |
||
GBDS-XSY-001 |
Sample diluent (YSXB No. 20160305)
|
Its principle is to inhibit RNase activity, which can effectively protect RNA from degradation, so as to have better dilution efficiency. It can be used to dilute samples such as serum, plasma or pathogen culture solution. |
1 mL/tube, 100 tubes/kit |
GBDS-XSY-002 |
2 mL/tube, 100 tubes/kit |
||
GBDS-XSY-003 |
3 mL/tube, 100 tubes/kit |
||
GBDS-XSY-004 |
6 mL/tube, 50 tubes/kit |
||
GBDS-XSY-005 |
6 mL/tube, 128 tubes/kit |
||
GBDS-XSY-006 |
400 mL/tube/ bag |
||
GBDS-XSY-007 |
40 mL/tube, 5 tubes/bag |
||
GBDS-XSY-008 |
200 mL/bottle/bag |
||
GBDS-XSY-009 |
500 mL/bottle/bag |
GBDS-XSY-010 |
Sample diluent (YSXB No. 20160303)
|
Its principle is to inhibit DNase activity, which can effectively protect DNA from degradation, so as to have better dilution efficiency. It can be used for dilution of DNA serum, plasma or pathogen culture solution. |
1 mL/tube, 100 tubes/kit |
GBDS-XSY-011 |
2 mL/tube, 100 tubes/kit |
||
GBDS-XSY-012 |
3 mL/tube, 100 tubes/kit |
||
GBDS-XSY-013 |
6 mL/tube, 50 tubes/kit |
||
GBDS-XSY-014 |
6 mL/tube, 128 tubes/kit |
||
GBDS-XSY-015 |
400 mL/tube/ bag |
||
GBDS-XSY-016 |
40 mL/tube, 5 tubes/bag |
||
GBDS-XSY-017 |
200 mL/bottle/bag |
||
GBDS-XSY-018 |
500 mL/bottle/bag |
||
GBDS-XSY-008 |
Disposable sampler (YSXB No. 20200106)
|
The equilibrium salt solution in the sample preservation solution provides a stable living environment, facilitates the preservation of viral infections, and helps the virus particles to be stored in colloidal dispersions, reducing or inhibiting the reaction of damaging nucleic acids. Antibiotics have broad-spectrum antibacterial effects. |
20 tests/kit |
GBDS-XSY-009 |
50 tests/kit |
||
GBDS-XSY-010 |
100 tests/kit |
||
GBDS-CYQ-001 |
Disposable sampler (YSXB No. 20210276) |
Inactivation principle: Guanidine thiocyanate in sample preservation solution can denature protein, dissolve protein and make protein secondary structure disappear, resulting in cell structure degradation and rapid separation of nucleoprotein from nucleic acid. It can inactivate the newly collected clinical samples by protein denaturation, greatly reducing the risk of biological infection in the sampling process of medical staff, sample transport process and inspection process. Inactivation time: The virus/other microorganisms in the samples can be inactivated by completely soaking the clinical samples in the preservation solution for 5 minutes. Stability principle: Guanidine salt not only has the function of precipitation protein, but also has the function of inhibiting nuclease, so as to ensure that the released nucleic acid is not degraded. It can protect the clinical samples that cannot be tested in time or the samples that need to be transported long distance, and prevent the degradation of viral nucleic acid in the samples. |
20 tests/kit |
GBDS-CYQ-002 |
50 tests/kit |
||
GBDS-CYQ-003 |
100 tests/kit |
GBDS-SFJ-009 |
Sample release agent (YSXB No. 20200597 )
|
Through the denaturation of proteins of cells or viruses, the dissolution of proteins and the disappearance of protein secondary structure leads to the degradation of cell or virus structure and the rapid separation of nuclear proteins from nucleic acids. The newly collected clinical samples of pathogens can be inactivated by protein denaturing, and the nucleic acid can be quickly released to protect the nucleic acid from degradation. The clinical samples of pathogens stored in the sample release agent can be directly used for PCR, real-time fluorescence PCR and other tests without heating or other nucleic acid extraction operations. |
0.5 mL/tube, 100 tubes/kit |
GBDS-SFJ-001 |
1 mL/tube, 100 tubes/kit |
||
GBDS-SFJ-002 |
2 mL/tube, 100 tubes/kit |
||
GBDS-SFJ-003 |
3 mL/tube, 100 tubes/kit |
||
GBDS-SFJ-004 |
5 mL/tube, 50 tubes/kit |
||
GBDS-SFJ-005 |
5 mL/tube, 128 tubes/kit |
||
GBDS-SFJ-006 |
6 mL/tube, 50 tubes/kit |
||
GBDS-SFJ-007 |
5 mL/tube, 128 tubes/kit |
||
GBDS-SFJ-008 |
40 mL/tube, 5 tubes/bag |
||
GBDS-TQY-001 |
Nucleic acid extraction or purification reagent (YSXB No. 20201476 ) |
The cells and viruses in the sample are lysed by lysate, and nucleic acid, protein and other impurities are released. The nucleic acid is selectively adsorbed on the surface of the magnetic bead, and then the residual protein, inorganic salt ions and organic impurities are removed by the action of the washing solution. Finally, pure nucleic acid was obtained by elution solution. It can be used for the extraction, enrichment and purification of nucleic acid. The treated products were used for clinical in vitro detection. |
Pre-packaged: 32 reaction/kit |
GBDS-TQY-002 |
Pre-packaged: 96 reaction/kit |
||
GBDS-TQY-003 |
Large package: 100 reaction/box |
||
GBDS-TQY-004 |
Nucleic acid extraction or purification reagent (YSXB No. 20211008) |
The cells and viruses in the sample are lysed by lysate, and nucleic acid, protein and other impurities are released. The nucleic acid is selectively adsorbed on the surface of the magnetic bead, and then the residual protein, inorganic salt ions and organic impurities are removed by the action of the washing solution. Finally, pure nucleic acid was obtained by elution solution. It can be used for nucleic acid extraction, enrichment and purification of FFPE samples. |
16 reaction/kit |