BULK PRE COATED NCM SHEETS & ANTIGEN EXTRACTION BUFFER - India CDSCO Medical Device Registration
BULK PRE COATED NCM SHEETS & ANTIGEN EXTRACTION BUFFER is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_e231a994356c6fbc4ae981c897a965e9_a315a14eacea0378c5ce6025fa5598af. This device is marketed under the brand name PathoCatchTM. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.
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Brand Name
PathoCatchTM
License Holder
Mylab Discovery S0lutions Pvt. LtdDevice Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
The BULK PRE COATED NCM SHEETS & ANTIGEN EXTRACTION BUFFER are intended to be used in COVID-19 Antigen Lateral Flow Test (PathoCatchTM) after its filling and packaging as per Company SOP; which is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab specimens directly from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. This final test kit after its secondary packaging and filling will be authorized for nonprescription home use with self-collected nasal swab specimens from individuals aged 18 years and older or with adult-collected nasal swab samples from individuals aged 2 years or older
HBsAg Test
Brand: PathoCatchTM
Mylab Discovery Solutions Pvt. Ltd.
HIV 1/2 Ab Test
Brand: PathoCatchTM
Mylab Discovery S0lutions Pvt. Ltd
HCV Ab Test
Brand: PathoCatchTM
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Syphilis Antibody Test
Brand: PathoCatchTM
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HBsAg FIA Test
Brand: PathoCatchTM
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COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE
Brand: PathoCatchTM
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HCV Ab FIA Test
Brand: PathoCatchTM
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COVID-19 ANTIGEN LATERAL FLOW TEST DEVICE OTC HOME TEST
Brand: PathoCatchTM
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COVID-19 FIA Test Kit
Brand: PathoCatchTM
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CMV Quantitative PCR Kit
Brand: Multigene-Multiplex Single tube format
Phenylalanine Detection Test
Brand: Multigene-Multiplex Single tube format
Malaria Pf Antigen Test
Brand: Multigene-Multiplex Single tube format
HIV 1/2 Ab Test
Brand: PathoCatchTM
HCV Ab Test
Brand: PathoCatchTM
G6PD Detection Test
Brand: Multigene-Multiplex Single tube format
Syphilis Antibody Test
Brand: PathoCatchTM
CRP FIA Test
Brand: Multigene-Multiplex Single tube format
MALARIA PF/PV ANTIGEN TEST
Brand: Multigene-Multiplex Single tube format
Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples
Brand: Multigene-Multiplex Single tube format