Rowley Biochemical Formalin Alcohol Acetic Acid F-119

GUDID F119852042008

Formalin Alcohol Acetic Acid Solution (FAA)

TRANSENE COMPANY, INC.

10% Neutral buffered formalin (alcoholic) IVD

• Primary Device ID: F119852042008
• NIH Device Record Key: 8ac63575-4edb-4b07-a4ec-484c96b03774
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rowley Biochemical Formalin Alcohol Acetic Acid
• Version Model Number: 1
• Catalog Number: F-119
• Company DUNS: 044815983
• Company Name: TRANSENE COMPANY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 4 Fluid Ounce

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	F119852042008 [Primary]

FDA Product Code

• IGF: Solution, Formalin-Alcohol-Acetic Acid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-23
• Device Publish Date: 2019-09-13

Devices Manufactured by TRANSENE COMPANY, INC.

• E3021A852042008 - Rowley Biochemical Crystal Violet Working Solution: 2019-09-24 Crystal Violet Working Solution
• E3031852042008 - Rowley Biochemical Sirius Red F3BA Solution: 2019-09-24 Sirius Red F3BA Solution, 1%
• E3101852042008 - Rowley Biochemical Carmine Stock: 2019-09-24 Best's Carmine Stock Solution
• E5852042008 - Rowley Biochemical Gelatin: 2019-09-24 Gelatin
• F3646852042008 - Rowley Biochemical Biebrich Scarlet Solution, 1%: 2019-09-24 Biebrich Scarlet solution, 1% aqueous
• F3833852042008 - Rowley Biochemical Gomori's Chromium Hematoxylin: 2019-09-24 Gomori's Chromium Hematoxylin
• R18852042008 - Rowley Biochemical Biebrich Scarlet, Certified: 2019-09-24 Biebrich Scarlet powder, BSC certified, CI 26905
• R34852042008 - Rowley Biochemical Congo Red, Certified: 2019-09-24 Congo Red, BSC Certified, CI 22120