Panels › Clinical Chemistry › Product code JJW · Class 1
Urinalysis Controls (Assayed And Unassayed)
Regulation 862.1660
0510(k)s in 12 months (61 all time)
1recalls in 12 months (22 all time)
17recalls that name a 510(k)
Top companies in JJW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Vivoo Sodium Test;
Vivoo Vitamin C Test;
Vivoo Hydration Test Open, Classified |
JJW | None listed |
| Oct 22, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2
6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test Open, Classified |
JJW | K874890 |
| Oct 16, 2024 | Beckman Coulter, Inc. Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device. Open, Classified |
JJW | K072640 |
| Jan 3, 2023 | Beckman Coulter, Inc. BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic
use only. Open, Classified |
JJW | K072640 |
| Feb 16, 2022 | Beckman Coulter, Inc. Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control. Open, Classified |
JJW | None listed |
| Apr 20, 2020 | Cardinal Health Inc. Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which ar Terminated |
JJW | None listed |
| Jul 25, 2019 | Randox Laboratories Ltd. Randox Urinalysis Control Level 2 (IVD)
Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips. Terminated |
JJW | K110846 |
| Dec 21, 2017 | Quantimetrix Corporation Dropper Plus Point-of-Care Urinalysis Dipstick Control kit
The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin Terminated |
JJW | K874890 |
| Mar 12, 2014 | Lin-Zhi International Inc Cannabinoids DAU Calibrator Control Level 1
(62.5 ng/mL)
This solution is prepared from non-sterile urine and should be handled as potentially infectious.
IVD;
The Cannabinoids (cTHC also known as T Terminated |
JJW | None listed |
| Nov 22, 2013 | Thermofisher Scientive MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Terminated |
JJW | K973451 |
| Sep 13, 2013 | Assuramed DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positiv Terminated |
JJW | None listed |
| May 15, 2013 | Iris Diagnostics Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12.
Product Usage: For in vitro diagnostic use with the iQ200 series. Terminated |
JJW | K832713 |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Combo Pak
(Distributed OUS)
Catalog Number: 1364E
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysi Terminated |
JJW | K943780 |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Combo Pak
(Distributed OUS only)
Catalog Number: 1364N
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for uri Terminated |
JJW | K943780 |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Combo Pak (Distributed OUS only)
Catalog Number: 1364M
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urin Terminated |
JJW | K943780 |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry
(Distributed OUS Only)
Catalog Number: 1360L
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used w Terminated |
JJW | K943780 |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Combo Pak
Catalog Number: 1364
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX posit Terminated |
JJW | K943780 |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine
Chemistry
Catalog Number: 5019
When used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Terminated |
JJW | K943780 |
| Jan 4, 2013 | Siemens Healthcare Diagnostics Inc Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry
Catalog Number:1360
Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strip Terminated |
JJW | K943780 |
| Aug 1, 2012 | Iris Diagnostics IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074.
Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes a Terminated |
JJW | K945913 |
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control.
The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis r Terminated |
JJW | K874890 |
| Jun 11, 2005 | International Remote Imaging Systems Inc IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. Terminated |
JJW | K945913 |
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