FDA Registration
Active
🇺🇸 United States
FORT WORTH DIAGNOSTICS LLC
Reg #: 3027062375
·
FEI: 3027062375
·
Expires 2026
Products
3
Proprietary Names
49
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- FORT WORTH DIAGNOSTICS LLC
- Registration Number
- 3027062375
- FEI Number
- 3027062375
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1120 South Freeway, Suite #120
- City
- Fort Worth
- State
- TX
- ZIP
- 76104
- Country
- US
Owner / Operator
- Firm Name
- Fort Worth Diagnostics LLC
- Operator Number
- 10087769
- Address
- 1120 South Freeway, Suite #120
- City
- Fort Worth
- State
- TX
- Postal Code
- 76104
- Country
- US
- Correspondent
- Winnie Boonyaratanakornkit
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2025-06-11 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2023-04-06 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2025-06-11 |
Proprietary Names
Stabilized Blood Dilution Matrix
Transport Media Dilution Matrix
Viral Transport Media Dilution Matrix
Group B Streptococcus Primer Set
Candida auris Primer Set
HSV-2 Primer Set
Candida krusei Primer Set
Influenza A Primer Set
Gardnerella vaginalis Primer Set
Ureaplasma Primer Set
Candida spp Primer Set
Influenza B Primer Set
Anaplasma Primer Set
HHV-6B Primer Set
Adenovirus Primer Set
Mycoplasma Primer Set
HPV Genotype 31 Primer Set
Candida glabrata Primer Set
SARS-CoV-2 Primer Set
Babesia Primer Set
Enterovirus Primer Set
RSV Primer Set
Megasphaera Primer Set
Borrelia miyamotoi Primer Set
JCV Primer Set
Measles Primer Set
Bacillus atrophaeus Primer Set
Parechovirus Primer Set
BVAB2 Primer Set
HHV-6A Primer Set
Ehrlichia Primer Set
HPV Genotype 45 Primer Set
Atopobium vaginae Primer Set
HSV-1 Primer Set
Asuragen Internal Process Control Primer Set
Borrelia Primer Set
VZV Primer Set
Influenza A H5N1 Primer Set
Babesia microti Primer Set
HPV Genotype 52 Primer Set
HPV Genotype 33 Primer Set
Measles Virus Control 1E5 cp/mL
Influenza A H5N1 Control 1E5 cp/mL
Borrelia Control 2E5 cp/mL
Babesia Control 1E5 cp/mL
Candida auris Control 5E3 cp/mL
B. miyamotoi Control 1E5 cp/mL
Ehrlichia Control 5E4 cp/mL
Anaplasma Control 1E4 cp/mL
Establishment Types
Manufacture Medical Device