FDA Registration
Active
🇺🇸 United States
BIOSAFE SUPPLIES, LLC
Reg #: 3014654360
·
FEI: 3014654360
·
Expires 2026
Products
9
Proprietary Names
10
Establishment Types
1
Classifications
9
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Registration Details
- Registration Name
- BIOSAFE SUPPLIES, LLC
- Registration Number
- 3014654360
- FEI Number
- 3014654360
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 230 Sunport Ln Ste 100
- City
- Orlando
- State
- FL
- ZIP
- 32809
- Country
- US
Regulatory Submissions
- 510(k) Number
- K982541
Owner / Operator
- Firm Name
- BioSafe Supplies, LLC
- Operator Number
- 10058583
- Address
- 9436 Southridge Park Court, Suite 400, Suite 400
- City
- Orlando
- State
- FL
- Postal Code
- 32819
- Country
- US
- Correspondent
- Nadine Monico
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | NNL | Class 1 | Pathology | No | 2021-07-21 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2021-07-21 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2021-07-29 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2021-08-30 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2021-07-21 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2021-07-19 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-07-19 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2021-07-20 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2021-07-21 |
Proprietary Names
Temp Control Mailer
Non-Sterile Specimen Storage
HPV FLOQSwab for HPV Self Collection Kit
COVID-19 Test
Alcohol Pads
Gauze
Single-Use Needle
Transport Vial
Specimen Transport Vial
Micro-Pipette
Establishment Types
Repack or Relabel Medical Device