FDA Registration
Active
🇺🇸 United States
Neo-Natal MSUD
Reg #: 3022178699
·
FEI: 3022178699
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- IMMUNOCENTRIX CORPORATION
- Registration Number
- 3022178699
- FEI Number
- 3022178699
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7041 Owensmouth Ave Ste 103
- City
- Canoga Park
- State
- CA
- ZIP
- 91303
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190266
Owner / Operator
- Firm Name
- ImmunoCentrix Corporation
- Operator Number
- 10084773
- Address
- 7041 Owensmouth Ave., Suite 103
- City
- Canoga Park
- State
- CA
- Postal Code
- 91303
- Country
- US
- Correspondent
- Mina Kateb
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| ß-Galactocerebrosidase (Galc) Newborn Screening Test System | QCM | Class 2 | Clinical Chemistry | No | 2023-03-07 |
| ß-Glucocerebrosidase (Gba) Newborn Screening Test System | PQV | Class 2 | Clinical Chemistry | No | 2023-03-07 |
| Alpha-L-Iduronidase (Idua) Newborn Screening Test System | PQT | Class 2 | Clinical Chemistry | No | 2023-03-07 |
| Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | PQW | Class 2 | Clinical Chemistry | No | 2023-03-07 |
| Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | PQU | Class 2 | Clinical Chemistry | No | 2023-03-07 |
| Acid-Sphingomyelinase (Asm) Newborn Screening Test System | QCL | Class 2 | Clinical Chemistry | No | 2023-03-07 |
Proprietary Names
Neo-Natal MSUD
Establishment Types
Manufacture Medical Device