REMEL, INC.

Address:12076 Santa Fe Trail Dr,LENEXA,KS,66215,US

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Filters

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

System, Blood Culturing (MDB) (8) Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth (JTZ) (1) Manual Antimicrobial Susceptibility Test Systems (JWY) (1)

Premarket Exempt

No Yes

Clear

NA - 00848838091063 Catalog Number :

Device Description : VERSATREK REDOX 1, 80 ML W/STIR BAR

Device Class : 1

Duns Number: 065769564

Premarket Exempt : No

Product Code : MDB

Prescription Use : No

Device Count : 50

NA - 00848838091070 Catalog Number :

Device Description : VERSATREK REDOX 2, 80ML

Device Class : 1

Duns Number: 065769564

Premarket Exempt : No

Product Code : MDB

Prescription Use : No

Device Count : 50

NA - 00848838091124 Catalog Number :

Device Description : VERSATREK MYCO GS

Device Class : 1

Duns Number: 065769564

Premarket Exempt : No

Product Code : MDB

Prescription Use : No

Device Count : 5

NA - 00848838091346 Catalog Number :

Device Class :

Duns Number: 065769564

Premarket Exempt : No

Product Code : JTZ

Prescription Use : No

Device Count : 10

NA - 00848838091438 Catalog Number :

Device Description : VERSATREK REDOX 2M, EZ DRAW 40ML

Device Class : 1

Duns Number: 065769564

Premarket Exempt : No

Product Code : MDB

Prescription Use : No

Device Count : 50

NA - 00848838091445 Catalog Number :

Device Description : VERSATREK REDOX 2, EZ DRAW 40ML

Device Class : 1

Duns Number: 065769564

Premarket Exempt : No

Product Code : MDB

Prescription Use : No

Device Count : 50

NA - 00848838091452 Catalog Number :

Device Description : VERSATREK REDOX 1, 40 ML W/STIR BAR

Device Class : 1

Duns Number: 065769564

Premarket Exempt : No

Product Code : MDB

Prescription Use : No

Device Count : 50

NA - 00848838091551 Catalog Number :

Device Class :

Duns Number: 065769564

Premarket Exempt : No

Product Code : JWY

Prescription Use : No

Device Count : 10

NA - 00848838091698 Catalog Number :

Device Description : VERSATREK MYCO BOTTLES, W/MODIFIED CAP

Device Class : 1

Duns Number: 065769564

Premarket Exempt : No

Product Code : MDB

Prescription Use : No

Device Count : 50

NA - 00848838091704 Catalog Number :

Device Description : VERSATREK MYCO PVNA, 5/BX

Device Class : 1

Duns Number: 065769564

Premarket Exempt : No

Product Code : MDB

Prescription Use : No

Device Count : 5

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