FDA Registration
Active
🇺🇸 United States
Enzyme Conjugate Diluent DF GPR (700 mL)
Reg #: 2020952
·
FEI: 2020952
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Alere San Diego Inc.
- Registration Number
- 2020952
- FEI Number
- 2020952
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 829 Towne Center Drive
- City
- Pomona
- State
- CA
- ZIP
- 91767
- Country
- US
Owner / Operator
- Firm Name
- Abbott
- Operator Number
- 9006731
- Address
- 100 Abbott Park Road, Dept. RX51/J55/MS 6134
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2008-02-11 |
Proprietary Names
Enzyme Conjugate Diluent DF GPR (700 mL)
Higher pH Antibody Diluent DF 2X NAD and G6P GPR (1000 mL)
Antibody Diluent DF 2X NAD and G6P GPR (1000 mL)
Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (1000 mL)
Lower pH Enzyme Conjugate Diluent DF GPR (600 mL)
Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (60 mL)
Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (100 mL)
Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (40 mL)
Alcohol Diluent GPR 60 mL
Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (1000 mL)
Antibody Diluent DF with Low NAD & G6P 2X NAD & G6P GPR (1000 Ml)
Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (100 mL)
Enzyme Conjugate Diluent DF GPR (70 mL)
Higher pH Antibody Diluent DF 2X NAD and G6P GPR (100 mL)
Antibody Diluent DF 2X NAD and G6P GPR (100 mL)
Enzyme Conjugate Diluent DF GPR (60 mL)
HEIA Enzyme Conjugate Diluent DF GPR (100 mL)
Enzyme Conjugate Diluent 2.5X DF with Low Sodium Bisulfite GPR (600 mL)
Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (400 mL)
HEIA Enzyme Conjugate Diluent DF GPR (100 mL) HEIA Enzyme Conjugate Diluent DF GPR (1000 mL)
Lower pH Enzyme Conjugate Diluent DF GPR (60 mL)
Enzyme Conjugate Diluent DF GPR (600 mL)
Establishment Types
Manufacture Medical Device