TRANSENE COMPANY, INC.

Address:10 Electronics Ave,DANVERS,MA,01923,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

Congo Red (ICH) (2) Biebrich Scarlet (ICN) (1) Alizarin Red (IDD) (1) Fluid, Bouin'S (IGN) (1) Muller'S Colloidal Iron (HZD) (1) Stain, Papanicolau (HZJ) (1) Crystal Violet For Histology (ICF) (1)

Premarket Exempt

Yes

Clear

Rowley Biochemical Biebrich Scarlet Acid Fuchsin - SO615852042008 Catalog Number : SO-615

Device Description : Biebrich Scarlet Acid Fuchsin solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICN

Prescription Use : No

Device Count : 1

Rowley Biochemical Alizarin Red S, 2% - SO636852042008 Catalog Number : SO-636

Device Description : Alizarin Red S Solution, 2% in water

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : IDD

Prescription Use : No

Device Count : 1

Rowley Biochemical Turk's Crystal Violet - SO755A852042008 Catalog Number : SO-755A

Device Description : Turk's Crystal Violet Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

Rowley Biochemical Congo Red 0.2% in Isopropanol - SO825852042008 Catalog Number : SO-825

Device Description : 0.2% Solution of Congo Red in Isopropyl Alcohol

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICH

Prescription Use : No

Device Count : 1

Rowley Biochemical Muller's Colloidal Iron Oxide Stock Solution - SO910852042008 Catalog Number : SO-910

Device Description : Muller's Colloidal Iron Oxide Stock Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : HZD

Prescription Use : No

Device Count : 1

Rowley Biochemical Alcoholic Bouin's Fluid - SO936852042008 Catalog Number : SO-936

Device Description : Alcoholic Bouin's Fluid

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : IGN

Prescription Use : No

Device Count : 1

Rowley Biochemical Harris Hematoxylin - SO942852042008 Catalog Number :

Device Description : Harris Hematoxylin without Mercury

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : HZJ

Prescription Use : No

Device Count : 1

Rowley Biochemical Congo Red, 0.1% Aqueous - SO959852042008 Catalog Number : SO-959

Device Description : Congo Red Solution, 0.1% concentration in water

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICH

Prescription Use : No

Device Count : 1

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