67 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
N Latex CDT Kit
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·September 5, 2018
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
FDA Enforcement
Class II
·Terminated·CTL Medical Corporation·March 27, 2019
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
FDA Enforcement
Class II
·Terminated·CTL Medical Corporation·March 27, 2019
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·April 29, 2020
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·March 23, 2022
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·August 18, 2021
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·May 19, 2021
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Enforcement
Class II
·Ongoing·Cordis Corporation·November 24, 2021
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·April 24, 2024
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·July 28, 2021
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·April 24, 2024
IgE Calibrator Series
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·October 12, 2016
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·January 2, 2019
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 31, 2023