FDA Registration
Active
🇺🇸 United States
H. pylori Antibody Rapid Test Dipstick
Reg #: 3005360469
·
FEI: 3005670738
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ACRO BIOTECH Inc.
- Registration Number
- 3005360469
- FEI Number
- 3005670738
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4650 Arrow Hwy Suite D6
- City
- Montclair
- State
- CA
- ZIP
- 91763
- Country
- US
Owner / Operator
- Firm Name
- Acro Biotech Inc.
- Operator Number
- 10043465
- Address
- 4650 Arrow Hwy Suite D6
- City
- Montclair
- State
- CA
- Postal Code
- 91763
- Country
- US
- Correspondent
- Joseph Fan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunohistochemical Assay, Helicobacter Pylori | OWF | Class 1 | Microbiology | No | 2020-04-06 |
Proprietary Names
H. pylori Antibody Rapid Test Dipstick
H. pylori Antigen Rapid Test Dipstick
H. pylori Antigen Rapid Test Cassette
H. pylori Antibody Rapid Test Cassette
Establishment Types
Repack or Relabel Medical Device