FDA Registration
Active
🇺🇸 United States
GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Reg #: 3016609999
·
FEI: 3016609999
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- GENABIO DIAGNOSTICS INC
- Registration Number
- 3016609999
- FEI Number
- 3016609999
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 19B Crosby Dr. Ste 220
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240545
Owner / Operator
- Firm Name
- Genabio Diagnostics Inc.
- Operator Number
- 10063095
- Address
- 19B Crosby Dr. Ste 220
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- weike mo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-09-19 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-09-19 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-09-19 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-09-19 |
Proprietary Names
GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198