FDA Registration
Active
🇺🇸 United States
Access Bio, Inc.
Reg #: 3024756665
·
FEI: 3024756665
·
Expires 2026
Products
10
Proprietary Names
18
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- Access Bio, Inc.
- Registration Number
- 3024756665
- FEI Number
- 3024756665
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7 Fitzgerald Ave
- City
- Monroe Township
- State
- NJ
- ZIP
- 08831
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251604
Owner / Operator
- Firm Name
- Access Bio, Inc.
- Operator Number
- 10028116
- Address
- 7 Fitzgerald Ave
- City
- Monroe Township
- State
- NJ
- Postal Code
- 08831
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2026-06-05 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-10-09 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-07-08 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-04-20 |
| Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests | QTU | Class N | Unknown | No | 2025-09-09 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | Class 2 | Microbiology | No | 2025-09-22 |
| Dengue Serological Reagents | OSU | Class 2 | Microbiology | No | 2015-08-06 |
| Plasmodium Spp. Detection Reagents | OAX | Class 2 | Microbiology | No | 2025-12-10 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2025-12-24 |
| Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | JBF | Class 2 | Hematology | No | 2012-10-16 |
Proprietary Names
CareSuperb COVID-19/Flu A&B Antigen Combo External Control
CareStart COVID-19 Antigen
on/go COVID-19 Antigen SelfTest
CareStart COVID-19 Antigen Home Test
CareStart COVID-19 MDx RT-PCR
CareStart COVID-19 Antibody External Controls
CareStart COVID-19 IgM/IgG
CareSuperb Mpox (Monkeypox) Antigen Rapid Test
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
CareSuperb COVID-19/Flu A&B Antigen Combo Test
CareStart Dengue Combo NS1 & IgM/IgG
CareStart Dengue NS1
CareStart Malaria Pf (HRP2)
CareStart Malaria Pf (HRP2/pLDH)
CareStart Malaria Pf/PAN (HRP2/pLDH) Combo
CareStart Malaria PAN (pLDH)
CareSuperb COVID-19 Antigen Home Test
CareStart G6PD
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only