FDA Registration
Active
🇺🇸 United States
Path-Tec
Reg #: 3007871198
·
FEI: 3007871198
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Path-Tec
- Registration Number
- 3007871198
- FEI Number
- 3007871198
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5700 Old Brim Rd
- City
- Midland
- State
- GA
- ZIP
- 31820
- Country
- US
Regulatory Submissions
- PMA Number
- P230001
Owner / Operator
- Firm Name
- BioTouch Global / Path-tec
- Operator Number
- 10024021
- Address
- 5700 Old Brim Road
- City
- Midland
- State
- GA
- Postal Code
- 31820
- Country
- US
- Correspondent
- Jennifer Block
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection | SBB | Class 3 | Unknown | No | 2025-09-26 |
| Cytology Kit | OKY | Class 2 | Obstetrics/Gynecology | No | 2009-08-20 |
| Blood Alcohol Kit (Excludes Hiv Testing) | OIC | Class 2 | Clinical Toxicology | No | 2009-08-20 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2023-03-28 |
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2025-03-25 |
| Urine Transport Kit (Excludes Hiv Testing) | OHZ | Class 1 | Pathology | No | 2009-08-20 |
| Phlebotomy Blood Collection Kit | OFM | Class 2 | Cardiovascular | No | 2009-08-20 |
Proprietary Names
Cytology Transport Kit
Blood Alcohol Collection Kit
Urine Transport Kit
Establishment Types
Repack or Relabel Medical Device