SARS-CoV-2 Test - FlowFlex - 1 pc
Code: FF1-09/26
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Product detailed description
SARS-CoV-2 Test - FlowFlex - 1 pc
Reliable self-test for the detection of the SARS-CoV-2 nucleocapsid antigen from an anterior nasal swab. Result within 10 minutes without laboratory equipment. Intended for lay use.
📄 Package Insert EN/DE | 📑 Declaration of Conformity | 📑 Shelf Life Extension to 3 Years
Pathogen: SARS-CoV-2
Sample Type: anterior nasal swab (self-collection)
Quick Instructions: Insert nasal swab into buffer tube, mix, attach dropper tip and apply 4 drops to the test cassette. Read the result after 10 minutes.
Test Performance
| Pathogen | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| SARS-CoV-2 | 97.1% | 99.5% | 98.8% |
Contents (1 test)
- 1× test cassette
- 1× extraction buffer tube
- 1× swab
- 1× waste bag
- 1× package insert (CZ)
Manufacturer: ACON Biotech (Hangzhou) Co., Ltd., China – leading global manufacturer of IVD tests.
Certification: CE mark under IV
Additional parameters
| Category: | IVD Respiratory |
|---|---|
| Pathogen: | SARS-CoV-2 |
| IVD Category: | Respiratory Diseases |
| Sample Type: | Nasal |
| Intended Use: | Home Use |
| Package Size: | Small Package |
| Brand / Manufacturer: | FlowFlex |
| LOT: | COV4095007 |
| ? EXP: | 09/26 + 1 rok (09/27) |