ELITECH MICROBIO

Address:Parc d activites du plateau,SIGNES Var,FR

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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

Discs, Strips And Reagents, Microorganism Differentiation (JTO) (1) Kit, Quality Control For Culture Media (JTR) (1)

Premarket Exempt

Yes

Clear

MYCOFAST US - 03661540100031 Catalog Number : 00050

Device Description : MYCOFAST US has been designed for the detection, enumeration and identification MYCOFAST US has been designed for the detection, enumeration and identification of Ureaplasma urealyticum (U.u.) and Mycoplasma hominis (M.h.) in various clinical sspecimens.

Device Class : 1

Duns Number: 299579792

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : Yes

Device Count : 1

MYCOPLASMA CONTROL - 03661540100505 Catalog Number : 00900

Device Description : The MYCOPLASMA CONTROL kit contains Ureaplasma urealyticum (U.u) and Mycoplasma The MYCOPLASMA CONTROL kit contains Ureaplasma urealyticum (U.u) and Mycoplasma hominis (M.h) strains and has been designed for the quality control of liquidmedia methods of in vitro urogenital mycoplasma diagnosis.

Device Class : 1

Duns Number: 299579792

Premarket Exempt : Yes

Product Code : JTR

Prescription Use : No

Device Count : 1

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