FDA Registration
Active
🇺🇸 United States
HSV 1/2 IgM Rapid Test Cassette
Reg #: 3005360469
·
FEI: 3005670738
·
Expires 2025
Products
1
Proprietary Names
3
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 |
|---|---|---|---|---|---|
| Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | PGI | Class 2 | Microbiology | No | 2016-05-09 |
Proprietary Names
HSV 1/2 IgM Rapid Test Cassette
HSV 1/2 IgG/IgM Combo Rapid Test Cassette
HSV 1/2 IgG Rapid Test Cassette
Establishment Types
Repack or Relabel Medical Device