FDA Registration
Active
🇹🇷 Türkiye
ISE Reagent, Glucose, CRP Latex
Reg #: 3011989923
·
FEI: 3011989923
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI
- Registration Number
- 3011989923
- FEI Number
- 3011989923
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Oruc Reis Mahallesi, Giyimkent 3 Sokak No 21A-23A Esenler
- City
- Istanbul
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K161837
Owner / Operator
- Firm Name
- Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti
- Operator Number
- 10060275
- Address
- Oruc Reis Mahallesi, Giyimkent 3 Sokak No 21A-23A Esenler
- City
- Istanbul
- State
- TR-34
- Postal Code
- 34235
- Country
- TR
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2025-05-30 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2025-05-30 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2025-05-30 |
| Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | NQD | Class 2 | Immunology | No | 2025-05-30 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2025-05-30 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2025-05-30 |
Proprietary Names
ISE Reagent, Glucose, CRP Latex
Establishment Types
Export Device to the United States But Perform No Other Operation on Device