FDA Registration
Active
🇺🇸 United States
BIOARRAY SOLUTIONS LIMITED
Reg #: 3005967741
·
FEI: 3005967741
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- BIOARRAY SOLUTIONS LIMITED
- Registration Number
- 3005967741
- FEI Number
- 3005967741
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 35 Technology Dr Ste 100
- City
- Warren
- State
- NJ
- ZIP
- 07059
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK130051
- PMA Number
- BP130026
Owner / Operator
- Firm Name
- BioArray Solutions Limited
- Operator Number
- 10041491
- Address
- 35 Technology Drive, Suite 100
- City
- Warren
- State
- NJ
- Postal Code
- 07059
- Country
- US
- Correspondent
- Jesdeep Sidhu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2014-08-18 |
| Quality Control For Molecular Immunohematology Tests | PFK | Class 2 | Hematology | No | 2014-08-18 |
| Dna-Probe, Human Chromosome | MAO | Class U | Unknown | No | 2012-07-30 |
| Test, Qualitative, For Hla, Non-Diagnostic | MZI | Class U | Unknown | No | 2024-11-14 |
| Molecular Erythrocyte Typing Test | PEP | Class 3 | Unknown | No | 2014-08-18 |
Proprietary Names
BioArray Array Imaging System (AIS) 400C
Array Imaging System AIS400C
PreciseType HEA BeadCheck Kit
HPA BeadChip Test Kit
HEA 1.2 BeadChip Test Kit
RHCE BeadChip Test Kit
RHD BeadChip Test Kit
MIA FORA NGS MFlex 11 HLA Typing Kit (24,96 &1152)
MIA FORA NGS MFlex 6 HLA Typing Kit (24,96 &1152)
Array Imaging System (AIS) 400D
Immucor PreciseType Human Erythrocyte Antigen Molecular BeadChip Test
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only