FDA Registration
Active
🇺🇸 United States
Transene Company, Inc.
Reg #: 1219125
·
FEI: 1219125
·
Expires 2026
Products
24
Proprietary Names
25
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- Transene Company, Inc.
- Registration Number
- 1219125
- FEI Number
- 1219125
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10 Electronics Ave
- City
- DANVERS
- State
- MA
- ZIP
- 01923
- Country
- US
Owner / Operator
- Firm Name
- TRANSENE CO INC DBA ROWLEY BIOCHEMICAL INC
- Operator Number
- 1219125
- Address
- 10 ELECTRONICS AVE., DANVERS INDUSTRIAL PARK
- City
- Danvers
- State
- MA
- Postal Code
- 01923
- Country
- US
- Correspondent
- CHRISTOPHER - CHRISTUK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aldehyde Fuchsin | IDB | Class 1 | Hematology | No | 1980-03-04 |
| Hematoxylin, Chrome Alum | ICI | Class 1 | Hematology | No | 1980-03-04 |
| Nuclear Fast Red | HZF | Class 1 | Hematology | No | 2013-06-10 |
| Biebrich Scarlet | ICN | Class 1 | Hematology | No | 1980-03-04 |
| Hematoxylin, Acid, Phosphotungstic | HZM | Class 1 | Hematology | No | 1980-03-04 |
| Stain, Papanicolau | HZJ | Class 1 | Hematology | No | 1980-03-04 |
| Hyaluronidase | IBD | Class 1 | Pathology | No | 1980-02-29 |
| Fluid, Bouin'S | IGN | Class 1 | Pathology | No | 1980-03-07 |
| Gelatin | IEX | Class 1 | Pathology | No | 1980-02-29 |
| Sirius Red | HZY | Class 1 | Hematology | No | 1980-03-04 |
| Mucicarmine | HZC | Class 1 | Hematology | No | 1980-03-04 |
| Solution, Fontanna Silver | HYE | Class 1 | Hematology | No | 1980-03-04 |
| Congo Red | ICH | Class 1 | Hematology | No | 1980-03-04 |
| Azocarmine G | ICS | Class 1 | Hematology | No | 1980-03-04 |
| Crystal Violet For Histology | ICF | Class 1 | Hematology | No | 1980-03-04 |
| Solution, Formalin-Alcohol-Acetic Acid | IGF | Class 1 | Pathology | No | 1980-03-07 |
| Diastase | IBC | Class 1 | Pathology | No | 1980-02-29 |
| Muller'S Colloidal Iron | HZD | Class 1 | Hematology | No | 1980-03-04 |
| Reagent, Schiff | HZT | Class 1 | Hematology | No | 1980-03-04 |
| Solution, Carnoy'S | IGM | Class 1 | Pathology | No | 1980-03-07 |
| Aniline | ICX | Class 1 | Hematology | No | 1980-02-29 |
| Best'S Carmine | ICO | Class 1 | Hematology | No | 1980-03-04 |
| Alizarin Red | IDD | Class 1 | Hematology | No | 1980-03-04 |
| Carbol Fuchsin | ICL | Class 1 | Hematology | No | 1980-03-04 |
Proprietary Names
ALDEHYDE FUCHSIN
CHROME HEMATOXYLIN SOLUTION
Nuclear Fast Red Solution
BIEBRICH SCARLET
PHOSPHOTUNGSTIC ACID
PAPANICOLAOU STAIN
TESTICULAR HYALURONIDASE
BOUIN'S FLUID
GELATIN
SIRIUS RED F3BA
MUCICARMINE STOCK SOLUTION
FONTANA SILVER NITRATE SOLUTION
ALCOHOLIC CONGO RED
AZOCARMINE G STAINING SOLUTION
CRYSTAL VIOLET SOLUTION
FORMALIN-ALCOHOL-A
BODIAN'S FLUID
DIASTASE POWDER
MULLER'S COLLOIDAL IRO
SCHIFF'S REAGENT SOLUTION
CARNOY'S FLUID
ANILINE
CARMINE STOCK SOLUTION
ALIZARIN RED S
ZIEHL'S CARBOL FUCHSIN SOLUTION
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device