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JOYSBIO - Nasal Antigen Rapid Test (Colloidal Gold) - Single Pack

from ₹220.64 /piece price excl. VAT
₹225.65 from 1000 to 1000 pieces
₹220.64 from 1001 to 5000 pieces

Status
Item sold. Check out similar offers below
Minimal order
1000 pieces
Available quantity
5000 pieces
Country
Greece
Grade
New  
Brands
europe - Only
SKU:
Joysbio Nasal Antigen Test
TARIC:
3822000000

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JOYSBIO - Nasal Antigen Rapid Test (Colloidal Gold) - Single Pack - description

1 piece JOYSBIO Corona Antigen NASAL test- International Shipping available
High-performance Antigen Test proved by an independent clinical study in Europe
CLINICAL STUDY DATE & LOCATION:November 2020 Apollosa (Benevento) Italy
SENSITIVITY: 98.72% (100% for samples with Ct values ≤33)
SPECIFICITY: 97.32%
CLINICAL STUDY POPULATION: 190 individuals, including 78 PCR-positives and 112 PCR-negatives
TEST TIME: 15–20 MINUTES
STORAGE CONDITION: 2°C–30°C
CE MARK
SAMPLE TYPE: Nasal (NS) swab
SHELF LIFE: 24 months
Less-invasive sample collection with nasal swabs
No instrumentation required
Cost-effective solution for large-scale testing

472 Single NASAL Antigen Tests - 1pc/box (single pack) per transport Carton
Transport Carton Dimensions : 0.63*0.52*0.41m
Mixed Weight of Carton :20 kg.

NASAL - SINGLE PACK INCLUDES
1 test cassette
1 Specimen sampling swab
1 Extraction tube
1 buffer solution
1 Instructions for use

For in vitro qualitative detection of SARS-CoV2 nucleocapsid antigen in nasal (NS) swab specimens directly from individuals who meet COVID-19 clinical and / or epidemiological criteria. JOYSBIO COVID-19 Antigen Rapid Test
Kit is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation.

Approval for professional use listed by the BfArm

SARS-COV-2 Antigen Rapid Test Kit - less-invasive COVID-19 testing with nasal (NS) swab

The test also recognizes the mutation from Great Britain - B117 as well as the mutation from South Africa -B.1.351 According to the BASG list, this test is also suitable for personal use in Austria. For Germany there is not yet a limited special approval from the BfArM for self-testing by laypeople; this has been applied for. Process number 5640-S-089_21 BfArM listed: List of antigen tests (bfarm.de) Test ID AT527 / 20 Manufacturer: JOYSBIO (Tianjin) Biotechnology CO., LTD. China EU-Rep: Lotus NL B.V. Product name according to the manufacturer: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Instructions for use in different languages
Returns excluded
Use as a self-test: The Nasal test can be used as a self-test by companies and institutions
Prerequisite: The staff must be trained. After the staff has been trained, the test can be carried out independently without the supervision of medical staff.


Enclosed files

Download file latest-sars-cov-2-ifu-9822-selftest11.pdf

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