FDA Device Registration & Listing · Sarasota, FL, US · Registration 3021186226
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Clinical Chemistry | Class 1 | 862.1300 | 2023-12-28 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | Clinical Chemistry | Class 1 | 862.1175 | 2023-12-28 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | Clinical Chemistry | Class 1 | 862.1485 | 2025-12-17 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1435 | 2023-12-28 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2026-02-18 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | Class 2 | 878.4850 | 2023-12-28 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | Class 2 | 878.4850 | 2023-12-28 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1115 | 2024-08-27 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | Class 1 | 862.1550 | 2023-12-28 |
| KHE | Reagent, Occult Blood | Hematology | Class 2 | 864.6550 | 2026-02-12 |
| KNK | Acid, Uric, Uricase (Colorimetric) | Clinical Chemistry | Class 1 | 862.1775 | 2024-08-27 |
| KSZ | System, Test, Automated Blood Grouping And Antibody | Hematology | Class 2 | 864.9175 | 2021-11-19 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2021-11-19 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2021-11-19 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2021-11-19 |
| DNK | Thin Layer Chromatography, Morphine | Clinical Toxicology | Class 2 | 862.3640 | 2021-11-19 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2021-11-19 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2021-11-19 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2021-11-19 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2021-11-19 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2021-11-19 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2021-11-19 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | Class U | N/A | 2021-11-19 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2021-11-19 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | Class 2 | 862.3910 | 2021-11-19 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2021-11-19 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2021-11-19 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2021-11-19 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2021-11-19 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2021-11-19 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2021-11-19 |
| NGI | Test, Morphine, Over The Counter | Clinical Toxicology | Class 2 | 862.3640 | 2021-11-19 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2021-11-19 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2021-11-19 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2021-11-19 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2026-05-16 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2026-04-28 |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Clinical Chemistry | Class 1 | 862.1095 | 2024-08-27 |
| KDT | Container, Specimen Mailer And Storage, Sterile | Pathology | Class 1 | 864.3250 | 2026-02-18 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | Class 1 | 862.1510 | 2024-08-27 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K790947 | Macomb Chemical Co. | AUTO ENZYMATIC CHOLESTEROL | 1979-06-28 |
| K885023 | Em Diagnostic Systems, Inc. | CHOLESTEROL TEST ITEM NUMBER: SR1011 | 1989-02-17 |
| K771508 | Instrumentation Laboratory CO | MULTISTAT III CHOLESTEROL TEST | 1977-09-13 |
| K162333 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo One Step Fecal Occult Blood (FOB) Test | 2017-05-14 |
| K830679 | Dow Instruments & Reagents, Inc. | URIC ACID COLORIMETRIC DETERMINATION | 1983-04-06 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0043-2024 | Universal Meditech Inc. | 1 | One Step Ovulation Test REF 200-01 |
| Z-0029-2013 | Alere San Diego, Inc. | 2 | Triage TOX Drug Screen Panel, Model# 94400.
Product Usage:
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. |
| Z-2787-2018 | Guangzhou Wondfo Biotech Co., Ltd. | 2 | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive. |
| Z-2788-2018 | Guangzhou Wondfo Biotech Co., Ltd. | 2 | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive. |
| Z-2789-2018 | Guangzhou Wondfo Biotech Co., Ltd. | 2 | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013167221 | KINGSWAY PHARMACEUTICALS DBA NFI, LLC | Bristol, TN, US |
| 1832216 | TECO DIAGNOSTICS | ANAHEIM, CA, US |
| 3010852191 | HONG KONG MEDSOURCING LIMITED | KOWLOON, HK |
| 8043323 | FOURSTAR GROUP INC. | TAIPEI, TW |
| 3023228837 | Intelimas Corporation | Londonderry, NH, US |
3021186226 when referencing this establishment in official correspondence.