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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)
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Top companies in JJW

DateFirm and productCodeLinked 510(k)
Feb 4, 2026Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Open, Classified
JJWNone listed
Oct 22, 2024Mckesson 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
JJWK874890
Oct 16, 2024Beckman 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
JJWK072640
Jan 3, 2023Beckman Coulter, Inc.
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Open, Classified
JJWK072640
Feb 16, 2022Beckman 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
JJWNone listed
Apr 20, 2020Cardinal 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
JJWNone listed
Jul 25, 2019Randox 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
JJWK110846
Dec 21, 2017Quantimetrix 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
JJWK874890
Mar 12, 2014Lin-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
JJWNone listed
Nov 22, 2013Thermofisher 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
JJWK973451
Sep 13, 2013Assuramed
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
JJWNone listed
May 15, 2013Iris 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
JJWK832713
Jan 4, 2013Siemens 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
JJWK943780
Jan 4, 2013Siemens 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
JJWK943780
Jan 4, 2013Siemens 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
JJWK943780
Jan 4, 2013Siemens 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
JJWK943780
Jan 4, 2013Siemens 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
JJWK943780
Jan 4, 2013Siemens 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
JJWK943780
Jan 4, 2013Siemens 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
JJWK943780
Aug 1, 2012Iris 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
JJWK945913
Jan 17, 2009Quantimetrix 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
JJWK874890
Jun 11, 2005International Remote Imaging Systems Inc
IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
Terminated
JJWK945913

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