LumiQuick Diagnostics Inc.
Santa Clara, CA, US
LUMIQUICK DIAGNOSTICS, INC. appears in FDA device records in Santa Clara, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 80 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 1 510(k) clearance for LumiQuick Diagnostics Inc. in 2013.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005984081 | 3005984081 | LUMIQUICK DIAGNOSTICS, INC. | 2946 SCOTT BLVD., SANTA CLARA, CA 95054 US | 2026 | and 49 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRRAmplifier And Signal Conditioner, Biopotential
- GTYAntigens, All Groups, Streptococcus Spp.
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- KXGApplicator, Absorbent Tipped, Sterile
- JLBAtp And Creatine Kinase (Enzymatic), Creatine
- MVEBiosensor, Immunoassay, Myoglobin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- QKPCoronavirus Antigen Detection Test System.
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- DBFFerritin, Antigen, Antiserum, Control
- LAFGas Chromatography, Methamphetamine
- LYRHelicobacter Pylori
- DGCIge, Antigen, Antiserum, Control
- MMIImmunoassay Method, Troponin Subunit
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- MJHLegionella, Spp., Elisa
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- QKOReagent, Coronavirus Serological
- KHEReagent, Occult Blood
- ETAReplacement, Ossicular Prosthesis, Total
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DMJTest Reagents For Ethyl Alcohol
- NFTTest, Amphetamine, Over The Counter
- PTHTest, Barbiturate, Over The Counter
- NFVTest, Benzodiazepine, Over The Counter
- NFWTest, Cannabinoid, Over The Counter
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- PTGTest, Methadone, Over The Counter
- NGGTest, Methamphetamine, Over The Counter
- NGLTest, Opiates, Over The Counter
- QBFTest, Propoxyphene, Over The Counter
- NWYTest, Qualitative, Detection Of Dengue Igm And Igg Antibodies
- QAWTest, Tricyclic Antidepressants, Over The Counter
- DKXThin Layer Chromatography, Barbiturate
- DJCThin Layer Chromatography, Methamphetamine
- DNKThin Layer Chromatography, Morphine
- DPNThin Layer Chromatography, Propoxyphene
- JHIVisual, Pregnancy Hcg, Prescription Use
- PYSZika Virus Serological Reagents (Emergency Use)
Recall records
Showing 25 of 80| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1416-2014 | CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1415-2014 | CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1414-2014 | Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1413-2014 | Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1412-2014 | Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1411-2014 | Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1410-2014 | Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1409-2014 | Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1408-2014 | K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1407-2014 | K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1406-2014 | Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1405-2014 | Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1404-2014 | Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1403-2014 | Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1402-2014 | Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1401-2014 | Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1400-2014 | Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1399-2014 | Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1398-2014 | Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1397-2014 | Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1396-2014 | Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1395-2014 | Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1394-2014 | Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1393-2014 | Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated | |
| Z-1392-2014 | Ketamine Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain