MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED

Address:PLOT NO. 99-B, LONAVLA INDUSTRIAL CO-OPERATIVE ESTATE LTD, NANGARGAON, LONAVLA,PUNE Maharashtra,IN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Coronavirus Antigen Detection Test System. (QKP) (4)

Premarket Exempt

Clear

CoviSelf - 08908016644008 Catalog Number : MDSC01

Device Description : COVID-19 Antigen Lateral Flow Test Device.

Device Class :

Duns Number: 860396703

Premarket Exempt : No

Product Code : QKP

Prescription Use : No

Device Count : 1

PathoCatch - 08908016644015 Catalog Number : MPF25

Device Description : COVID-19 Antigen Fluorescence Immunoassay Kit

Device Class :

Duns Number: 860396703

Premarket Exempt : No

Product Code : QKP

Prescription Use : Yes

Device Count : 1

Gazelle PathoCatch - 08908016644022 Catalog Number : MGPF25

Device Description : COVID-19 Antigen Fluorescence Immunoassay Kit

Device Class :

Duns Number: 860396703

Premarket Exempt : No

Product Code : QKP

Prescription Use : Yes

Device Count : 1

CoviSelf - 08908016644039 Catalog Number : MDSC02

Device Description : COVID-19 Antigen Lateral Flow Test Device.

Device Class :

Duns Number: 860396703

Premarket Exempt : No

Product Code : QKP

Prescription Use : No

Device Count : 1

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