Home Health US, Incorporated
Sarasota, FL, US
HOME HEALTH US INCORPORATED appears in FDA device records in Sarasota, FL. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3021186226 | 3021186226 | HOME HEALTH US INCORPORATED | 7672 15th St E, Sarasota, FL 34243 US | 2026 | and 43 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- KNKAcid, Uric, Uricase (Colorimetric)
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- KDTContainer, Specimen Mailer And Storage, Sterile
- NNIContainer, Specimen, Non-Sterile
- FLLContinuous Measurement Thermometer
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LAFGas Chromatography, Methamphetamine
- QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- FMINeedle, Hypodermic, Single Lumen
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- LKBPad, Alcohol, Device Disinfectant
- LNWPaper, Obstetric Ph
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- KHEReagent, Occult Blood
- JRERefractometer For Clinical Use
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- KSZSystem, Test, Automated Blood Grouping And Antibody
- 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
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- PTGTest, Methadone, Over The Counter
- NGGTest, Methamphetamine, Over The Counter
- NGITest, Morphine, Over The Counter
- NGLTest, Opiates, Over The Counter
- NGMTest, Phencyclidine (Pcp), Over The Counter
- QBFTest, Propoxyphene, Over The Counter
- QAWTest, Tricyclic Antidepressants, Over The Counter
- LJXTest, Urine Leukocyte
- DJCThin Layer Chromatography, Methamphetamine
- DNKThin Layer Chromatography, Morphine
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0226-2026 | One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. | Due to incorrect/lack of Unique Device Identifier (UDI) codes. | Class III | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain