FDA Registration
Active
🇺🇸 United States
Sekisui Diagnostics, LLC
Reg #: 2030538
·
FEI: 1000520007
·
Expires 2026
Products
21
Proprietary Names
28
Establishment Types
6
Classifications
21
Registration Details
- Registration Name
- Sekisui Diagnostics, LLC
- Registration Number
- 2030538
- FEI Number
- 1000520007
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6659 Top Gun St
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240280
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 |
|---|---|---|---|---|---|
| Control, Fecal Occult Blood | OSL | Class 2 | Hematology | No | 2018-12-18 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2025-05-16 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2011-02-25 |
| Test, Vaginal, Bacterial Sialidase | MXB | Class 1 | Microbiology | No | 2011-02-25 |
| Antisera, All Groups, Streptococcus Spp. | GTZ | Class 1 | Microbiology | No | 2011-02-25 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2020-03-31 |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | Class 1 | Microbiology | No | 2016-11-17 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2019-03-19 |
| Enzyme Linked Immunoabsorbent Assay, Rotavirus | LIQ | Class 1 | Microbiology | No | 2019-02-19 |
| Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | GNX | Class 1 | Microbiology | No | 2017-06-15 |
| Antisera, Fluorescent, Human Metapneumovirus | OMG | Class 2 | Microbiology | No | 2019-01-07 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2017-06-15 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2018-12-18 |
| Giardia Spp. | MHI | Class 2 | Microbiology | No | 2011-02-25 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2016-07-26 |
| Kit, Screening, Trichomonas | JWZ | Class 1 | Microbiology | No | 2011-02-25 |
| Kit, Quality Control For Culture Media | JTR | Class 1 | Microbiology | No | 2011-11-17 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2011-11-17 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2024-03-18 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2011-02-25 |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | Class 2 | Microbiology | No | 2026-01-12 |
Proprietary Names
OSOM hCG Combo Test
OSOM Card Pregnancy Test
OSOM hCG Urine Test
OSOM hCG Urine Control Set
OSOM Strep A Test
Rapidtesta RSV-Adeno Kit
OSOM RSV/Adeno Kit EU
RapidTesta RSV-Adeno Co.A 10T
RapidTesta hs Adeno 10T
RSV/Adeno Test (197E/198E)
Sekisui Medical Adenovirus Dipstick (425868)
Sekisui Medical RSV/Adeno Test (466588)
OSOM RSV/ Adeno Control Kit
OSOM RSV/ Adeno
RapidTesta Ultra Strep A Co.A 10T
RapidTesta Ultra Strep A 10T
OSOM Trichomonas Control Kit
OSOM Trichomonas Test
OSOM Ultra Strep A Test
OSOM hCG Serum Control Set
COVID-19 Antigen Home Test
OSOM FLU Home Test
OSOM Flu SARS-CoV-2 Combo Home Test
OSOM COVID-19 Antigen Rapid Test
OSOM COVID-19 Antigen Control Kit
OSOM Flu SARS-CoV-2 Combo Control Kit
OSOM Flu SARS-CoV-2 Combo Test
OSOM COVID-19 Antigen Home Test
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility