Strep A Test - VivaDiag - 1 pc
Code: VIVASTREP1-06/26
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Product detailed description
Strep A Test - VivaDiag - 1 pc
Professional immunochromatographic test for detecting group A Streptococcus directly from a throat swab. Result within 10 minutes without laboratory equipment. Intended for healthcare professionals.
📄 Package Insert | 📑 Declaration of Conformity | 📑 IVDD Certificate Extension
Pathogen: Streptococcus pyogenes (Strep A)
Sample Type: throat swab
Quick Instructions: Add reagents to the tube, insert the swab, mix thoroughly, attach the dropper, and add 3 drops to the test cassette. Read the result within 10 minutes.
Test Performance
- Sensitivity: 95.56%
- Specificity: 98.73%
- Accuracy: 97.57%
Contents (1 test)
- 1× test cassette
- 1× sterile throat swab
- 1× reagent 1
- 1× reagent 2
- 1× tube with dropper
- 1× tube holder
- 1× instructions for use (CZ)
Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd., China
Certification: CE mark under IVDD 98/79/EC – in vitro diagnostic medical device.
💡 Price is for 1 test in individual packaging.
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Additional parameters
| Category: | IVD Infectious |
|---|---|
| Pathogen: | Strep A |
| IVD Category: | Infectious Diseases |
| Sample Type: | Oropharyngeal |
| Intended Use: | Professional Use |
| Package Size: | Small Package |
| Brand / Manufacturer: | VivaDiag |
| LOT: | E2406064 |
| EXP: | 06/26 |