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Diazo Colorimetry, Bilirubin

Regulation 862.1110

1510(k)s in 12 months (235 all time)
0recalls in 12 months (19 all time)
19recalls that name a 510(k)
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Top companies in CIG

Company510(k)sRecalls
Em Diagnostic Systems, Inc.210
Abbott Laboratories151
Data Medical Associates, Inc.100
Diagnostic Chemicals , Ltd.80
Siemens Healthcare Diagnostics, Inc.35
Ortho-Clinical Diagnostics, Inc.16
Synermed, Inc.70
Harleco60
Pointe Scientific, Inc.,42
Roche Diagnostics41
DateFirm and productCodeLinked 510(k)
Sep 6, 2024Siemens Healthcare Diagnostics, Inc.
Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Open, Classified		 CIGK061719
Sep 21, 2023Ortho-Clinical Diagnostics, INc.
VITROS XT Chemistry Products TBIL-ALKP Slides
Open, Classified		 CIGK190807
Jul 13, 2020Ortho-Clinical Diagnostics
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total
Terminated		 CIGK190807
Jul 13, 2020Ortho-Clinical Diagnostics
VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrati
Terminated		 CIGK840606
Feb 13, 2020Siemens Healthcare Diagnostics, Inc.
Dimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnos
Terminated		 CIGK061719
Feb 13, 2020Siemens Healthcare Diagnostics, Inc.
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the clinical chemistry syst6em
Terminated		 CIGK060628
Oct 16, 2019Roche Diagnostics Operations, Inc.
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/H
Terminated		 CIGK131544
Aug 15, 2019Beckman Coulter Inc
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cart
Terminated		 CIGK902801
Aug 15, 2019Beckman Coulter Inc
Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/car
Terminated		 CIGK934068
Apr 13, 2019Roche Diagnostics Corporation
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative d
Terminated		 CIGK131544
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CIGK862359
Jun 14, 2017Medtest Holdings, Inc.
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitati
Terminated		 CIGK040391
Mar 19, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive
Terminated		 CIGK840880
K922072
Nov 19, 2013Siemens Healthcare Diagnostics
Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage:
Terminated		 CIGK050374
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS
Terminated		 CIGK840880
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bi
Terminated		 CIGK840606
Apr 16, 2012Abbott Laboratories Inc.
Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates.
Terminated		 CIGK022339
Mar 5, 2010Pointe Scientific, Inc.
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
Terminated		 CIGK040391
Apr 17, 2009Pointe Scientific, Inc.
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bil
Terminated		 CIGK040391

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