ClearanceBrief
Panels › Clinical Chemistry › Product code CGN · Class 2

Acid, Folic, Radioimmunoassay

Regulation 862.1295

0510(k)s in 12 months (64 all time)
0recalls in 12 months (41 all time)
37recalls that name a 510(k)
Get daily alerts for CGNSample briefCSV

Top companies in CGN

DateFirm and productCodeLinked 510(k)
Aug 12, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Open, Classified
CGNK001266
K984166
Feb 21, 2023Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
Open, Classified
CGNK172201
Feb 21, 2023Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
Open, Classified
CGNK172201
Feb 21, 2023Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
Open, Classified
CGNK172201
Jan 21, 2020Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Terminated
CGNK010050
Jan 21, 2020Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Terminated
CGNK010050
Jan 21, 2020Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Terminated
CGNK010050
Nov 30, 2018Tosoh Bioscience Inc
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
Terminated
CGNK964349
K992365
Jul 12, 2018Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Open, Classified
CGNK001266
May 4, 2018Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate (FOL)
Terminated
CGNK010050
May 4, 2018Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Folic Acid
Terminated
CGNK993254
Sep 4, 2015Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Terminated
CGNK010050
May 7, 2014Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2
Terminated
CGNK010050
Dec 24, 2013Siemens Healthcare Diagnostics
IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyz
Terminated
CGNK943705
Sep 10, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Terminated
CGNK010050
Sep 10, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Terminated
CGNK010050
Sep 10, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Terminated
CGNK010050
Sep 10, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Terminated
CGNK010050
Dec 11, 2012Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic
Terminated
CGNK010050
Oct 10, 2012Beckman Coulter Inc.
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum
Terminated
CGNK060774
Apr 29, 2010Baxter Healthcare Corp.
Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 mL type II glass bottles; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60
Terminated
CGNNone listed
Apr 15, 2009Abbott Laboratories
AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on t
Terminated
CGNK972232
Sep 21, 2008Beckman Coulter Inc
Access and Access 2 Immunoassay System
Terminated
CGNK922823
Jul 11, 2007Abbott Laboratories
AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Terminated
CGNK972232
May 9, 2007Abbott Laboratories, Inc
ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits)and 07K60-30 (4 x 500 test kits); manufactured by Abbott Ireland Diagnostic Divis
Terminated
CGNNone listed
Sep 29, 2006Roche Diagnostics Corp.
Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
Terminated
CGNK043318
Apr 28, 2005Abbott Laboratories MPG
ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
Terminated
CGNNone listed
Nov 30, 2004Beckman Coulter Inc
Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
Terminated
CGNK922823
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 600
Terminated
CGNK943691
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK943691
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx Folate Mode 1 Calibrator 3.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK943691
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK943691
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each level), Low Control L 2.5 ng/mL and High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK943691
K972232
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
AxSYM Folate Medium Control Pack , list 3C81-11, the pack contains 8 - 1 mL vials of Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK972232
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK972232
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK972232
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-
Terminated
CGNK023397
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK023397
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK023397
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNK023397
Jan 6, 2004Abbott Laboratories HPD/ADD/GPRD
IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
CGNNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.