Strep A Test - VivaDiag - 25 pcs
Code: VIVASTREP25
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Product detailed description
Strep A Test - VivaDiag - 25 pcs
Professional test for the qualitative detection of Streptococcus pyogenes (group A) directly from a throat swab. Result within 10 minutes without the need for laboratory equipment.
📄 Package Insert | 📑 Declaration of Conformity | 📑 IVDD Certificate Extension
Pathogen: Streptococcus pyogenes (group A)
Sample Type: throat swab
Quick Instructions: Collect throat swab, insert directly into extraction tube with two reagents, mix, apply 4 drops to the test cassette. Read result in 10 minutes.
Test Performance
- Relative Sensitivity: 95.56%
- Relative Specificity: 98.73%
- Accuracy: 97.57%
Contents (25 tests)
- 25× test cassette
- 25× sterile swab
- 25× extraction tube
- 25× reagent A
- 25× reagent B
- 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 per 1 test within the 25-pack.
📦 Interested in wholesale? Contact us.
Additional parameters
| Category: | IVD Infectious |
|---|---|
| Pathogen: | Strep A |
| IVD Category: | Infectious Diseases |
| Sample Type: | Oropharyngeal |
| Intended Use: | Professional Use |
| Package Size: | Large Package |
| Brand / Manufacturer: | VivaDiag |
| LOT: | E2502062 |
| EXP: | 08/26 |