LIKELY ACTIVELAST SEEN IN FEDERAL DATA AUG 2026 · 2 SOURCES
Operating signal within 24 months, or from a single source.
What they make
In-Vitro Diagnostic Substance Manufacturing325413Sekisui Diagnostics produces clinical chemistry reagents, kits, calibrators, controls, linearity materials, enzymes, biosensors.Unclear
SUMMARIZED FROM THE COMPANY’S OWN WEBSITE
Products
Made or handled here · 9
Antigens, All Groups, Streptococcus Spp. · Antisera, All Groups, Streptococcus Spp. · Control, Fecal Occult Blood · Devices Detecting Influenza A, B, And C Virus Antigens · Giardia Spp. · Kit, Screening, Trichomonas · Single (Specified) Analyte Controls (Assayed And Unassayed) · System, Test, Infectious Mononucleosis · Visual, Pregnancy Hcg, Prescription UseWhere these came from
9 from FDA device registration · Federal registry
FDA device establishment 3017772438, product code GTY; proprietary names: OSOM Ultra Strep A Test
CAREERS
Careers page — seen SEP 8, 2026
Where it is
32.91093, -117.17416 · CENSUS TIGER
Other plants nearby
| Facility | City | Industry | Status | Distance |
|---|---|---|---|---|
| Wondfo USA CO LTD | San Diego | In-Vitro Diagnostic Substance Manufacturing 325413 | UNVERIFIED | 0.1 KM |
| Sekisui Diagnostics LLC | San Diego | Pharmaceutical Preparation Manufacturing 325412 | LIKELY ACTIVE | 0.4 KM |
| Innopop INC | San Diego | Biological Product (except Diagnostic) Manufacturing 325414 | UNVERIFIED | 0.7 KM |
| Scripps Laboratories | San Diego | Biological Product (except Diagnostic) Manufacturing 325414 | UNVERIFIED | 0.8 KM |
| Cellibre, INC. | San Diego | All Other Basic Organic Chemical Manufacturing 325199 | ACTIVE | 0.8 KM |
Also at this address
No other federal record shares this street address.
WHERE THIS RECORD COMES FROM — 2 FEDERAL SOURCES, 6 FIELDS
Every fact on this page traces to a public federal filing. The table below names which register holds this facility, whether that register proves the plant operates or only that it exists, and when each of them last saw it.
EPA cross-references this facility in RCRAINFO · EPA site type STATIONARY.
| Source | Evidence | First seen | Last seen |
|---|---|---|---|
| FDA DEVICES | OPERATING | AUG 2026 | AUG 2026 |
| EPA FRS | EXISTENCE | JUL 2021 | JUL 2021 |
FIELD BY FIELD — WHICH SOURCE SUPPLIED WHAT
| FIELD | SOURCE | SIGNAL |
|---|---|---|
| ADDRESS LINE1 | EPA FRS | JUL 2026 |
| CITY | EPA FRS | JUL 2026 |
| GEOM | EPA FRS | JUL 2026 |
| NAME | EPA FRS | JUL 2026 |
| RCRA GENERATOR STATUS | EPA ECHO | SEP 2026 |
| STATE | EPA FRS | JUL 2026 |
Status is computed from independent sources; nothing here is self-reported unless marked Claimed.


