Guangzhou BioKey Healthy Technology Co.Ltd
| Payment Terms | L/C, T/T, Western Union |
| Supply Ability | 100,000 per day |
| Delivery Time | Depending on order quantity |
| Packaging Details | Carton package |
| Package | 96 tests/kit |
| expiration date | 12 months |
| Storage | -20±5℃ |
| Applicable | Micgene 244/244 IVD（BIO-KEY） |
| LoD | 1×10000 copies/ml |
| CV | ≤5% |
| Brand Name | Biokey |
| Model Number | BIK-QL-H0019 |
| Certification | CE |
| Place of Origin | Guangzhou China |
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Product Specification
| Payment Terms | L/C, T/T, Western Union | Supply Ability | 100,000 per day |
| Delivery Time | Depending on order quantity | Packaging Details | Carton package |
| Package | 96 tests/kit | expiration date | 12 months |
| Storage | -20±5℃ | Applicable | Micgene 244/244 IVD（BIO-KEY） |
| LoD | 1×10000 copies/ml | CV | ≤5% |
| Brand Name | Biokey | Model Number | BIK-QL-H0019 |
| Certification | CE | Place of Origin | Guangzhou China |
| High Light | MG PCR Detection Kit ，Mycoplasma Genitalium PCR Detection Kit ，MG STD STI Test Kit | ||
Intended use:
Principle:
Main components:
| No. | Components | BIK-QL-H0019 |
|
1 |
PCR Enzyme Mix(Lyophilized) |
96 tests/bottle |
| 2 | MG Primer-Probe Mix | 100 μL/vial |
| 3 | Enzyme Mix Buffer (5×) | 400 μL/vial |
| 4 | Positive Control | 100 μL/tube |
| 5 | Negative Control | 100 μL/tube |
| 6 | RNase-free water | 1mL/tube |
| 7 | Paraffin oil | 1.5mL/tube*2 |
Specimen requirements:
1. Specimen type
Urine or urethral swabs for men, and female urine, cervical swabs, or vaginal swab samples
2. Specimen Preservation
The specimen can be stored for 3 months at -20±5℃ and for a long time below -70℃
PCR Amplification condition:
PCR amplification according to the following procedures:
| Step | Cycle number | Temperature | Time |
| 1 | 1 | 95℃ | 3min |
| 2 | 40 | 95℃ | 10s |
| 60℃ | 30s collect fluorescent |
Instrument detection channel selection: FAM and HEX/VIC.
Quality control:
| Ct value | |
| Negative Control | No Ct |
| Positive Control | ≤30 |
| IC of samples | ≤38 |
Note: Negative Control, Positive Control and IC of samples must be performed correctly, otherwise the sample results is invalid.
Data analysis and interpretation:
The following sample results are possible:
| Ct value | Result Analysis | |
| 1# | No Ct | negative |
| 2# | ≤38 | Positive |
| 3# | 38~40 | Re-test; if it is still 38~40, report as 2# |
Operation details please check from IFU!
Company Details
Business Type:
Manufacturer,Distributor/Wholesaler,Exporter,Seller
Year Established:
2003
Total Annual:
5M-10M
Employee Number:
100~200
Ecer Certification：
Verified Supplier
Bio key Health is a high-tech enterprise with integrating R&D, production and sales&marketing in Guangzhou. Since 2003. Bio Key was founded by the "Thousand Talents Program" entrepreneurial team and the overseas senior automation equipment development engineer team. &n... Bio key Health is a high-tech enterprise with integrating R&D, production and sales&marketing in Guangzhou. Since 2003. Bio Key was founded by the "Thousand Talents Program" entrepreneurial team and the overseas senior automation equipment development engineer team. &n...
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