FDA Registration
Active
🇺🇸 United States
CSTM 90ML PJW/70MLS 10%NBF/SAFRANINO CLS
Reg #: 1419341
·
FEI: 1419341
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Leica Biosystems Richmond, Inc.
- Registration Number
- 1419341
- FEI Number
- 1419341
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5205 Us Highway 12
- City
- Richmond
- State
- IL
- ZIP
- 60071
- Country
- US
Owner / Operator
- Firm Name
- Leica Biosystems, division of Leica Microsystems, Inc.
- Operator Number
- 10054155
- Address
- 21440 W. Lake Cook Road, Floor 5
- City
- Deer Park
- State
- IL
- Postal Code
- 60010
- Country
- US
- Correspondent
- Adam Blunier
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 2017-06-23 |
Proprietary Names
CSTM 90ML PJW/70MLS 10%NBF/SAFRANINO CLS
CSTM 20ML PJ/ CELLNETIX #4 UNWIND
480ML PREFILLED PJ (DL)
AffirmSeal Jar 10% Neutral Buffered Formalin (20ml)
PROSTATE KIT (16 JARS/BX)
PROSTATE KIT (12 JARS/BX)
CUSTOM 20ML PREFILLED PJ CBL PATH
AffirmSeal Jar 10% Neutral Buffered Formalin (40ml)
CSTM 60ML PJ W/TAMPER PROOF LABEL
PROSTATE BIOPSY COREDISH 12 COMPARTMENT
AffirmSeal Jar 10% Neutral Buffered Formalin (60ml)
AffirmSeal Jar 10% Neutral Buffered Formalin (90ml)
10% MILLONIG'S MODIFIED P; 10% NEUT
CSTM 60ML PJ/ CELLNETIX
CSTM 120ML PJ W/TAMPER PROOF LABEL
CUSTOM 60ML PREFILLED PJ CBL PATH
CSTM 120ML PJ/CARLE CLINIC
CUSTOM 90ML PREFILLED PJ CLS
PROSTATE KIT (8 JARS/BX)
AffirmSeal Jar 10% Neutral Buffered Formalin (120ml)
Neutral Buffered Formalin Concentrate
Establishment Types
Manufacture Medical Device