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

Carbol Fuchsin (ICL) (2) Congo Red (ICH) (1) Crystal Violet For Histology (ICF) (1) Hematoxylin, Acid, Phosphotungstic (HZM) (1) Mucicarmine (HZC) (1) Reagent, Schiff (HZT) (1) Solution, Fontanna Silver (HYE) (1) Alizarin Red (IDD) (1) Stain, Papanicolau (HZJ) (1)

Premarket Exempt

Yes

Clear

Rowley Biochemical Mucicarmine Stock Solution - SO382852042008 Catalog Number : SO-382

Device Description : Mucicarmine Stock Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : HZC

Prescription Use : No

Device Count : 1

Rowley Biochemical PTAH Staining Solution - SO398852042008 Catalog Number : SO-398

Device Description : Phosphotungstic Acid Hematoxylin Staining Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : HZM

Prescription Use : No

Device Count : 1

Rowley Biochemical Schiff's Reagent - SO429852042008 Catalog Number : SO-429

Device Description : Schiff's Reagent for Histological Staining

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : HZT

Prescription Use : No

Device Count : 1

Rowley Biochemical Scott's Water - SO430852042008 Catalog Number : SO-430

Device Description : Scott's Water Solution for Papanicolau Staining

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : HZJ

Prescription Use : No

Device Count : 1

Rowley Biochemical Alizarin Red S 1% - SO438852042008 Catalog Number : SO-438

Device Description : Alizarin Red S Solution, 1% in water

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : IDD

Prescription Use : No

Device Count : 1

Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution - SO471852042008 Catalog Number : SO-471

Device Description : Ziehl Neelsen Carbol Fuchsin Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICL

Prescription Use : No

Device Count : 1

Rowley Biochemical Carbol Fuchsin - SO490852042008 Catalog Number : SO-490

Device Description : Carbol Fuchsin

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICL

Prescription Use : No

Device Count : 1

Rowley Biochemical Congo Red 1% Aqueous - SO496852042008 Catalog Number : SO-496

Device Description : Congo Red Staining Solution, 1% Aqueous

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICH

Prescription Use : No

Device Count : 1

Rowley Biochemical Crystal Violet, Lillie's - SO500852042008 Catalog Number : SO-500

Device Description : Lillie's Crystal Violet Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

Rowley Biochemical Fontana's Silver Nitrate Working Solution - SO605852042008 Catalog Number : SO-605

Device Description : Fontana's Silver Nitrate Working Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : HYE

Prescription Use : No

Device Count : 1

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