FDA Registration
Active
🇺🇸 United States
ACD RNA ISH Probe Napsin A
Reg #: 3009161685
·
FEI: 3009161685
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Advanced Cell Diagnostics, Inc.
- Registration Number
- 3009161685
- FEI Number
- 3009161685
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7707 Gateway Blvd, Suite 200
- City
- Newark
- State
- CA
- ZIP
- 94560
- Country
- US
Owner / Operator
- Firm Name
- Advanced Cell Diagnostics
- Operator Number
- 10051491
- Address
- 7707 Gateway
- City
- Newark
- State
- CA
- Postal Code
- 94560
- Country
- US
- Correspondent
- Bob Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2016-07-22 |
Proprietary Names
ACD RNA ISH Probe Napsin A
ACD RNA ISH Probe PPIB (Positive Control)
RNAscope ISH Probe SARS-CoV-2
ACD RNA ISH Probe CMV
ACD RNA ISH Probe HPV-6
ACD RNA ISH Probe HPV-16
ACD RNA ISH Probe TTF-1 (Thyroid Transcription Factor-1)
RNAscope ISH Probe Lambda
ACD RNA ISH Probe (concentrate) HPV-11
ACD RNA ISH Probe UBC (Positive Control)
ACD RNA ISH Probe (concentrate) HPV-33
ACD RNA ISH Probe (concentrate) HPV-31
ACD RNA ISH Probe EBV
ACD RNA ISH Probe HPV-31
ACD RNA ISH Probe Albumin
ACD RNA ISH Probe DapB (Negative Control)
RNAscope ISH Probe Kappa
ACD RNA ISH Probe (concentrate) HPV-18
RNAscope ISH Probe IGLL5
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device