FDA Registration
Active
🇺🇸 United States
Sekisui Diagnostics, LLC
Reg #: 3017772438
·
FEI: 3017772438
·
Expires 2026
Products
9
Proprietary Names
9
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Sekisui Diagnostics, LLC
- Registration Number
- 3017772438
- FEI Number
- 3017772438
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6740 Cobra Way
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992658
Owner / Operator
- Firm Name
- Sekisui Diagnostics, LLC
- Operator Number
- 10035388
- Address
- 6659 Top Gun Street
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2011-02-25 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2018-12-18 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2011-02-25 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2011-02-25 |
| Giardia Spp. | MHI | Class 2 | Microbiology | No | 2011-02-25 |
| Control, Fecal Occult Blood | OSL | Class 2 | Hematology | No | 2018-12-18 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2011-11-17 |
| Antisera, All Groups, Streptococcus Spp. | GTZ | Class 1 | Microbiology | No | 2011-02-25 |
| Kit, Screening, Trichomonas | JWZ | Class 1 | Microbiology | No | 2011-02-25 |
Proprietary Names
OSOM Ultra Strep A Test
OSOM hCG Serum Control Set
OSOM Strep A Test
OSOM hCG Combo Test
OSOM Card Pregnancy Test
OSOM Trichomonas Control Kit
OSOM Trichomonas Test
OSOM hCG Urine Test
OSOM hCG Urine Control Set
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility