Panels › Hematology › Product code LCP · Class 2
Assay, Glycosylated Hemoglobin
Regulation 864.7470
0510(k)s in 12 months (249 all time)
1recalls in 12 months (103 all time)
98recalls that name a 510(k)
Top companies in LCP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Heritage Labs International LLC Appraise Hemoglobin A1c Test , Product K7600, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection sup Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (Carolina Care Plan), Product K7400, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specim Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (Alere), Product K7300, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (IBM Care Advantage), Product K7200, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specim Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (Consumers Life Insurance Company), Product K7100, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, an Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C (Retail) Collection Kit, Product K7050, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collect Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (Medical Mutual of Ohio), Product K7000, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood sp Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Alere Blood Collection Kit (Carolina Care Plan), Product K6900, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood speci Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Alere Blood Collection Kit (Consumer Life Insurance), Product K6700, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Nationwide DBS Collection Kit, Product K4003, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection sup Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise DBS Kit, Product K4002, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Super Valu (Appraise) Combo Kit, Product A1773, each kit packed in a bag or envelope. (This kit has since changed to product A8302, which will be listed separately due to the new part number.) Each Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Wellness Kits, Product A1769, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001- Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Wellness Kits, Product A1768, each kit packed in a bag or envelope in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001- Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Wellness Kits w/Purple Top, Product A1767, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, ND Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Wellness Single Kit/Bulk, Product A1751, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Benicomp Supplies Kit, Product A1740. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and forms packaged in a plastic pouch.
Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs St. Jude Childhood Cancer Study Kit, Product A1185. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0 and blood specimen collection supplies.
Blood s Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs DBS/Urine Collection Kit, Product A1101, packed in bags in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood sp Terminated |
LCP | K990899 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests.
For the determination of Hemoglobin A1c in human whole blood.
Contents:
1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buff Terminated |
LCP | K070819 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set.
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-e Terminated |
LCP | K070819 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,.
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood u Terminated |
LCP | K924122 K991127 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made Terminated |
LCP | K991127 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made Terminated |
LCP | K991127 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Hemoglobin A1c Program Buffer B,
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange h Terminated |
LCP | K040872 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests,
IVD, Made in United States.
Kit contains:
1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer
2. Elution Buffer B 1 x 1500 mL Terminated |
LCP | K040872 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests,
IVD, Made in United States.
Kit contains:
1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer
2. Elution Buffer B 1 x 1500 mL Terminated |
LCP | K040872 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. D-10 Hemoglobin A1c Program Elution Buffer 2:
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid ch Terminated |
LCP | K031043 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. D-10 Hemoglobin A1c Supplemental Reagent Pack:
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid c Terminated |
LCP | K031043 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. D-10 Hemoglobin A1c Program Reorder Pack; 400 tests;
For the determination of Hemoglobin A1c in human whole blood. IVD
Contents:
1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer
2. Elution Terminated |
LCP | K031043 |
| Sep 6, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack.
Calibrator/Diluent Set.
IVD.
Kit components:
Elution Buffer A, 2 x 2500 mL
Elution Buffer B, 1 x 2100 mL
Wash/Diluent Solution, 1 x 2500 mL
C Terminated |
LCP | K070819 |
| Jul 27, 2011 | Bio-Rad Laboratories Inc D-10 Dual Program Reorder Pack;
contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2.
Bio-Rad Laboratories Inc. Hercules, CA.
Product Usage:
Short Prog Terminated |
LCP | K041444 |
| May 10, 2011 | Beckman Coulter Inc. Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472
Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c) Terminated |
LCP | K031380 |
| Apr 13, 2011 | Bio-Rad Laboratories, Inc., Hercules, CA Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette;
Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufa Terminated |
LCP | K031043 |
| Apr 11, 2011 | Bio-Rad Laboratories Inc Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, Terminated |
LCP | None listed |
| Apr 6, 2011 | Bio-Rad Laboratories Inc Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Labo Terminated |
LCP | K063400 |
| Feb 17, 2011 | Bio-Rad Laboratories Inc Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured Terminated |
LCP | K040872 K063400 |
| Feb 15, 2011 | Bio-Rad Laboratories Inc Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Cali Terminated |
LCP | K070819 |
| Oct 22, 2010 | Bio-Rad Laboratories Inc in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK
The Terminated |
LCP | K041635 |
| Oct 21, 2010 | Bio-Rad Laboratories Inc in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Labo Terminated |
LCP | K041635 |
| Jun 25, 2010 | Bio-Rad Laboratories Inc VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Terminated |
LCP | K984268 |
| Jun 25, 2010 | Bio-Rad Laboratories Inc VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA.
Provi Terminated |
LCP | K984268 |
| Mar 5, 2010 | Bio-Rad Laboratories Inc Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA Terminated |
LCP | K070452 |
| Feb 26, 2010 | Bio-Rad Laboratories Inc Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA.
Intended Use: For the percent determination of hemoglobin A1c in human whole Terminated |
LCP | K063400 |
| May 19, 2009 | Bio-Rad Laboratories Inc Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA
Measurement of percent hemoglobin Alc is effective in monitoring Terminated |
LCP | K063643 |
| Mar 24, 2009 | Bio-Rad Laboratories Inc Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA
Provides an integrated method for sample preparation, sepa Terminated |
LCP | K063400 |
| Dec 17, 2008 | Alfa Wassermann, Inc. ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators.
Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitr Terminated |
LCP | K070734 |
| Sep 23, 2008 | Cholestech Corp Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c). Terminated |
LCP | K041635 |
| Aug 31, 2007 | Metrika Inc A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary Terminated |
LCP | K051321 |
| Nov 18, 2005 | Provalis Diagnostics Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product Terminated |
LCP | K041635 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.