IVD Research, LLC.
Carlsbad, CA, US
IVD RESEARCH, LLC. appears in FDA device records in Carlsbad, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for IVD Research, LLC. between 2002 and 2009. The busiest year on record is 2003, with 2. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K081064 | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF | MHI | Substantially Equivalent | |
| K032897 | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 | LLH | Substantially Equivalent | |
| K031059 | IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 | MHJ | Substantially Equivalent | |
| K024113 | IVD CRYPTO/GIARDIA DFA | MHI | Substantially Equivalent | |
| K020583 | IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 | MHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031468 | 3002023342 | IVD RESEARCH, LLC. | 5909 SEA LION PLACE, SUITE D, Carlsbad, CA 92010 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni
- GMOAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
- MHJCryptosporidium Spp.
- MDTElisa, Trichinella Spiralis
- MHIGiardia Spp.
- QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter
- GWDIndirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- LLHReagents, Clostridium Difficile Toxin
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain