FDA Device Registration & Listing · Wellington, FL, US · Registration 1066444
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2018-12-28 |
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | Class 2 | 862.1345 | 2018-12-28 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | Class 2 | 862.1345 | 2018-12-28 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | Class 2 | 878.4850 | 2022-12-02 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2018-12-28 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | Class 2 | 878.4850 | 2023-12-27 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | Class 2 | 878.4850 | 2022-12-02 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | Class 2 | 878.4850 | 2022-12-02 |
| IRT | Pad, Heating, Powered | Physical Medicine | Class 2 | 890.5740 | 2021-11-10 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2024-11-13 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2019-12-16 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2019-12-16 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2018-12-28 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K103744 | Quantimetrix Corp. | DROPPER A1C DIABETES CONTROL | 2011-05-12 |
| K981281 | Roche Diagnostics GmbH | ELECSYS CALCHECK FERRITIN | 1998-04-24 |
| K981278 | Roche Diagnostics GmbH | ELECSYS CALCHECK CA 125II | 1998-04-23 |
| K143687 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | 2015-07-17 |
| K143376 | Siemens Healthcare Diagnostics, Inc. | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material | 2014-12-23 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0007-2008 | Tosoh Bioscience Inc | 1 | 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic. |
| Z-0378-06 | Instrumentation Laboratory Co. | 2 | GEM PREMIER 3000 |
| Z-2165-2011 | Instrumentation Laboratory Co. | 2 | Instrumentation Laboratory GEM Premier 4000
PN 00025000000
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus |
| Z-0004-2009 | Lifescan Inc | 2 | One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count.
Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm. |
| Z-0042-06 | Abbott Laboratories Medisense Products | 2 | FreeStyle FLASH Blood Glucose Monitoring System;
Recalling Firm/Manufacturer:
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007652384 | MICROBIX | Mississauga Ontario, CA |
| 3014353121 | VIDAN DIAGNOSTICS, LLC | San Antonio, TX, US |
| 3008514395 | Telcare, LLC | Linwood, PA, US |
| 3012118659 | ASCENSIA DIABETES CARE HOLDINGS AG | Basel Basel-Stadt, CH |
| 1319681 | ORTHO-CLINICAL DIAGNOSTICS, INC. | Rochester, NY, US |
1066444 when referencing this establishment in official correspondence.