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Panels › Clinical Chemistry › Product code JJY · Class 1

Multi-Analyte Controls, All Kinds (Assayed)

Regulation 862.1660

0510(k)s in 12 months (673 all time)
2recalls in 12 months (95 all time)
73recalls that name a 510(k)
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Top companies in JJY

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Microgenics Corporation
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP
Open, Classified
JJYNone listed
Nov 17, 2025POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Open, Classified
JJYK924061
Oct 30, 2025Microgenics Corporation
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagn
Open, Classified
JJYNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
Open, Classified
JJYNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Open, Classified
JJYNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Open, Classified
JJYNone listed
Mar 22, 2024Ortho-Clinical Diagnostics
VITROS Performance Verifier II
Open, Classified
JJYNone listed
Mar 22, 2024Ortho-Clinical Diagnostics
VITROS Performance Verifier I
Open, Classified
JJYNone listed
Mar 19, 2024Mckesson Medical-Surgical Inc. Corporate Office
Abbott Point of Care Control Control i-STAT Level 3 1.7 mL
Open, Classified
JJYK972868
Mar 19, 2024Mckesson Medical-Surgical Inc. Corporate Office
Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL
Open, Classified
JJYK972868
Oct 12, 2023TECHNO-PATH MANUFACTURING LTD.
Multichem P, Part Code 08P90-10
Open, Classified
JJYNone listed
Oct 12, 2023TECHNO-PATH MANUFACTURING LTD.
Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
Open, Classified
JJYNone listed
Oct 12, 2023TECHNO-PATH MANUFACTURING LTD.
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Open, Classified
JJYNone listed
Sep 19, 2023Randox Laboratories Ltd.
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Open, Classified
JJYK140971
Aug 23, 2023Randox Laboratories Ltd.
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin,
Open, Classified
JJYK110904
Jun 28, 2023Randox Laboratories Ltd.
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Open, Classified
JJYK140522
Jun 28, 2023Randox Laboratories Ltd.
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Open, Classified
JJYK140522
Jan 5, 2023Randox Laboratories Ltd.
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
Open, Classified
JJYK972608
Jan 5, 2023Randox Laboratories Ltd.
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Open, Classified
JJYK972608
Jan 5, 2023Randox Laboratories Ltd.
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
Open, Classified
JJYK972608
May 19, 2022Chromsystems Instruments & Chemicals GmbH
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Terminated
JJYNone listed
May 19, 2022Chromsystems Instruments & Chemicals GmbH
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Terminated
JJYNone listed
Nov 2, 2020Chromsystems Instruments & Chemicals GmbH
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of
Terminated
JJYNone listed
Nov 2, 2020Chromsystems Instruments & Chemicals GmbH
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of
Terminated
JJYNone listed
Nov 2, 2020Chromsystems Instruments & Chemicals GmbH
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of t
Terminated
JJYNone listed
Oct 29, 2020Chromsystems Instruments & Chemicals GmbH
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Completed
JJYNone listed
Oct 29, 2020Chromsystems Instruments & Chemicals GmbH
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Completed
JJYNone listed
Oct 16, 2020Ortho Clinical Diagnostics Inc
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,
Open, Classified
JJYK904768
Jul 28, 2020Medline Industries Inc
Control, Calibrator Verified, Triage BNP, Model ALR88755
Terminated
JJYK072892
Mar 20, 2020Utak Laboratories Inc
Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
Terminated
JJYK883147
Feb 18, 2020Randox Laboratories Ltd.
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for t
Open, Classified
JJYK140971
Dec 13, 2019Randox Laboratories Ltd.
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Terminated
JJYNone listed
Oct 4, 2019Randox Laboratories, Limited
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Terminated
JJYK110534
Oct 4, 2019Randox Laboratories, Limited
Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Terminated
JJYK110534
Oct 4, 2019Randox Laboratories, Limited
Randox Liquid Cardiac Controls Catalogue Number CQ5051
Terminated
JJYK110534
Jun 11, 2019Randox Laboratories, Limited
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is f
Terminated
JJYK942458
Jun 10, 2019Randox Laboratories, Limited
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Terminated
JJYNone listed
Apr 9, 2019Abbott Laboratories
Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th
Terminated
JJYK132751
Apr 9, 2019Abbott Laboratories
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th
Terminated
JJYK132751
Mar 15, 2019Response Biomedical Corp.
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Si
Terminated
JJYK110534
Mar 11, 2019Randox Laboratories Ltd.
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Terminated
JJYK110534
Feb 13, 2019Randox Laboratories Ltd.
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas ana
Terminated
JJYK093384
Feb 7, 2019Randox Laboratories Ltd.
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproduc
Terminated
JJYK112337
Feb 7, 2019Randox Laboratories Ltd.
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and
Terminated
JJYK140522
Feb 7, 2019Randox Laboratories Ltd.
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and repr
Terminated
JJYK040379
Oct 2, 2018Randox Laboratories Ltd.
Liquid Cardiac Control, CQ5053
Terminated
JJYK110534
Oct 2, 2018Randox Laboratories Ltd.
Liquid Cardiac Control, CQ5052
Terminated
JJYK110534
Oct 2, 2018Randox Laboratories Ltd.
Liquid Cardiac Control, CQ5051
Terminated
JJYK110534
Jun 13, 2018Randox Laboratories Ltd.
Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
Terminated
JJYK972608
Jun 13, 2018Randox Laboratories Ltd.
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Terminated
JJYK972608

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