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

Crystal Violet For Histology (ICF) (3) Congo Red (ICH) (1) Diastase (IBC) (1) Fluid, Bouin'S (IGN) (1) Formalin, Neutral Buffered (IFP) (1) Hyaluronidase (IBD) (1) Carbol Fuchsin (ICL) (1) Stain, Papanicolau (HZJ) (1)

Premarket Exempt

Yes

Clear

Rowley Biochemical Bouin's Fluid - SO306852042008 Catalog Number : SO-306

Device Description : Bouin's Fluid

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : IGN

Prescription Use : No

Device Count : 1

Rowley Biochemical Congo Red 0.5% Aqueous - SO312852042008 Catalog Number : SO-312

Device Description : Congo Red Staining Solution, 0.5% Aqueous

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICH

Prescription Use : No

Device Count : 1

Rowley Biochemical Crystal Violet Staining Solution - SO316852042008 Catalog Number : SO-316

Device Description : Crystal Violet Staining Solution, 1% Aqueous

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

Rowley Biochemical Crystal Violet, Hucker's - SO317852042008 Catalog Number : SO-317

Device Description : Hucker's Crystal Violet Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

Rowley Biochemical Crystal Violet Stirling - SO319852042008 Catalog Number : SO-319

Device Description : Stirling Crystal Violet Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

Rowley Biochemical Diastase Powder - SO322852042008 Catalog Number : SO-322

Device Description : Diastase Powder

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : IBC

Prescription Use : No

Device Count : 1

Rowley Biochemical EA Counterstain - SO323852042008 Catalog Number : SO-323

Device Description : EA Counterstaining Solution for Papanicolau Staining

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : HZJ

Prescription Use : No

Device Count : 1

Rowley Biochemical Neutral Buffered Formalin - SO334852042008 Catalog Number :

Device Description : Neutral Buffered Formalin

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : IFP

Prescription Use : No

Device Count : 1

Rowley Biochemical Hyaluronidase Powder - SO351852042008 Catalog Number : SO-351

Device Description : Hyaluronidase Powder

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : IBD

Prescription Use : No

Device Count : 1

Rowley Biochemical Kinyoun's Carbol Fuchsin Solution - SO359852042008 Catalog Number : SO-359

Device Description : Kinyoun's Carbol Fuchsin Solution

Device Class : 1

Duns Number: 044815983

Premarket Exempt : Yes

Product Code : ICL

Prescription Use : No

Device Count : 1

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