FDA Registration
Active
🇺🇸 United States
Birlinn BCR-ABL1 p210 IS Control Panel C240
Reg #: 3005959679
·
FEI: 3005959679
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MAINE MOLECULAR QUALITY CONTROLS, INC.
- Registration Number
- 3005959679
- FEI Number
- 3005959679
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 23 Mill Brook Rd
- City
- Saco
- State
- ME
- ZIP
- 04072
- Country
- US
Owner / Operator
- Firm Name
- MAINE MOLECULAR QUALITY CONTROLS, INC.
- Operator Number
- 9081510
- Address
- 23 Mill Brook Road, Mill Brook Business Park
- City
- Saco
- State
- ME
- Postal Code
- 04072
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Quality Control Material, Genetics, Rna | QIG | Class 2 | Microbiology | No | 2019-10-09 |
Proprietary Names
Birlinn BCR-ABL1 p210 IS Control Panel C240
Birlinn BCR-ABL1 p210 IS Panel C230
Xpert BCR-ABL IS Panel C130
Xpert BCR-ABL 0%IS
Xpert BCR-ABL IS p210 Linearity Panel C207
Xpert BCR-ABL IS p210 Panel C206
Establishment Types
Manufacture Medical Device