FDA Registration
Active
🇺🇸 United States
Measles IgM Antibodies
Reg #: 3038371011
·
FEI: 3038371011
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- INNOTECH BIO CORPORATION
- Registration Number
- 3038371011
- FEI Number
- 3038371011
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 430 S CATARACT AVE FL 2ND
- City
- San Dimas
- State
- CA
- ZIP
- 91773
- Country
- US
Owner / Operator
- Firm Name
- Innotech Bio Corporation
- Operator Number
- 10093272
- Address
- 430 S CATARACT AVE FL 2ND
- City
- San Dimas
- State
- CA
- Postal Code
- 91773
- Country
- US
- Correspondent
- Fang Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Research Use Only/Immunology Devices | OTR | Class N | Unknown | No | 2025-05-21 |
Proprietary Names
Measles IgM Antibodies
Measles IgG Antibodies
Flu A&H5 / SARS-CoV-2&Flu B Ag Combo Rapid Test Cassette (Swab)
Measles IgG ELISA Kit
Measles IgM ELISA Kit
Flu A&B / RSV&SARS-CoV-2 Ag Combo Rapid Test Cassette (Swab)
Mycobacterium tuberculosis Antibody Detection Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Remanufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device