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)
Top companies in CGN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 Open, Classified |
CGN | K001266 K984166 |
| Feb 21, 2023 | Siemens 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 |
CGN | K172201 |
| Feb 21, 2023 | Siemens 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 |
CGN | K172201 |
| Feb 21, 2023 | Siemens 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 |
CGN | K172201 |
| Jan 21, 2020 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell
SMN: 10331250 Terminated |
CGN | K010050 |
| Jan 21, 2020 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells
SMN: 10325366 Terminated |
CGN | K010050 |
| Jan 21, 2020 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells
SMN:10310308 Terminated |
CGN | K010050 |
| Nov 30, 2018 | Tosoh 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 |
CGN | K964349 K992365 |
| Jul 12, 2018 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 Open, Classified |
CGN | K001266 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Folate (FOL) Terminated |
CGN | K010050 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi Folic Acid Terminated |
CGN | K993254 |
| Sep 4, 2015 | Siemens 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 |
CGN | K010050 |
| May 7, 2014 | Siemens 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 |
CGN | K010050 |
| Dec 24, 2013 | Siemens 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 |
CGN | K943705 |
| Sep 10, 2013 | Siemens 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 |
CGN | K010050 |
| Sep 10, 2013 | Siemens 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 |
CGN | K010050 |
| Sep 10, 2013 | Siemens 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 |
CGN | K010050 |
| Sep 10, 2013 | Siemens 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 |
CGN | K010050 |
| Dec 11, 2012 | Siemens 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 |
CGN | K010050 |
| Oct 10, 2012 | Beckman 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 |
CGN | K060774 |
| Apr 29, 2010 | Baxter 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 |
CGN | None listed |
| Apr 15, 2009 | Abbott 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 |
CGN | K972232 |
| Sep 21, 2008 | Beckman Coulter Inc Access and Access 2 Immunoassay System Terminated |
CGN | K922823 |
| Jul 11, 2007 | Abbott Laboratories AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CGN | K972232 |
| May 9, 2007 | Abbott 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 |
CGN | None listed |
| Sep 29, 2006 | Roche Diagnostics Corp. Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122. Terminated |
CGN | K043318 |
| Apr 28, 2005 | Abbott 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 |
CGN | None listed |
| Nov 30, 2004 | Beckman Coulter Inc Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer. Terminated |
CGN | K922823 |
| Jul 20, 2004 | Abbott 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 |
CGN | K943691 |
| Jul 20, 2004 | Abbott 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 |
CGN | K943691 |
| Jul 20, 2004 | Abbott 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 |
CGN | K943691 |
| Jul 20, 2004 | Abbott 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 |
CGN | K943691 |
| Jul 20, 2004 | Abbott 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 |
CGN | K943691 K972232 |
| Jul 20, 2004 | Abbott 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 |
CGN | K972232 |
| Jul 20, 2004 | Abbott 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 |
CGN | K972232 |
| Jul 20, 2004 | Abbott 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 |
CGN | K972232 |
| Jul 20, 2004 | Abbott 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 |
CGN | K023397 |
| Jul 20, 2004 | Abbott 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 |
CGN | K023397 |
| Jul 20, 2004 | Abbott 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 |
CGN | K023397 |
| Jul 20, 2004 | Abbott 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 |
CGN | K023397 |
| Jan 6, 2004 | Abbott 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 |
CGN | None listed |
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