FDA.reportPublic FDA data

Hemoglobin A2 Normal Control

Primary DI
00817869020182
Brand
Hemoglobin A2 Normal Control
Company
ANALYTICAL CONTROL SYSTEMS INC
Model
HC-111
Catalog number
HC-111
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KHGWhole Blood Hemoglobin Determination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHGWhole Blood Hemoglobin DeterminationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K802569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K802569000ABNORMAL HEMOGLOBIN CONTROLMarilyn L. Amick1980-11-12KHG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817869020189PackageGS16In Commercial Distribution
00817869020182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081786902018910817869020189
00817869020182008178690201828178690201820817869020182

GMDN Terms#

Term, Definition table
TermDefinition
Inherited haemoglobinopathy IVD, controlA material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
038232682
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817869020359Hemoglobin Variant Control KitHC-121HC-1212019-11-19
00817869020335Hemotec Whole Blood Control Kit LargeWBC-HT-111WBC-HT-1112019-11-14
00817869020342Hemotec Whole Blood Control Kit SmallWBC-HT-1012019-11-14
00817869020311Hemotec Whole Blood Control Kit LargeSC-125, SC-126, H2O2019-07-24
00817869020007.02M Calcium ChlorideCR-109CR-1092019-01-31
00817869020014Slide Platelet Aggregation Test ReagentCR-121-1CR-121-12019-01-31
00817869020052Hemoglobin AFSC ControlHC-102HC-1022019-01-31
00817869020069Hemoglobin NAFSC ControlHC-102NHC-102N2019-01-31
00817869020076Hemoglobin AF ControlHC-103HC-1032019-01-31
00817869020083Hemoglobin AC ControlHC-105HC-1052019-01-31
00817869020090Hemoglobin AS ControlHC-104HC-1042019-01-31
00817869020106Hemoglobin AC Control PowderHC-105PHC-105P2019-01-31
00817869020113Hemoglobin F Normal ControlHC-106HC-1062019-01-31
00817869020120Hemoglobin F Abnormal ControlHC-106ELHC-106EL2019-01-31
00817869020137Hemoglobin G6PDH Normal ControlHC-108HC-1082019-01-31
00817869020144Hemoglobin G6PDH Deficient ControlHC-108DEHC-108DE2019-01-31
00817869020151Hemoglobin G6PDH Intermediate ControlHC-108INHC-108IN2019-01-31
00817869020168Hemoglobin Total Normal ControlHC-110HC-1102019-01-31
00817869020175Hemoglobin Total Linearity ControlHC-110LINHC-110LIN2019-01-31
00817869020199Hemoglobin A2 Elevated ControlHC-111ELHC-111EL2019-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048534000840CleanerEKF-diagnostic GmbHKHG2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHKHG2022-12-21
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHKHG2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHKHG2021-05-10
00817869020052Hemoglobin AFSC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020069Hemoglobin NAFSC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020076Hemoglobin AF ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020083Hemoglobin AC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020090Hemoglobin AS ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020106Hemoglobin AC Control PowderANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020113Hemoglobin F Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020120Hemoglobin F Abnormal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020137Hemoglobin G6PDH Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020144Hemoglobin G6PDH Deficient ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020151Hemoglobin G6PDH Intermediate ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020168Hemoglobin Total Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020175Hemoglobin Total Linearity ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020199Hemoglobin A2 Elevated ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020205Hemoglobin AE ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020212Hemoglobin FAS ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020229Hemoglobin AD ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020236HemoglobinAG Philadelphia ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00657498000144STAT-Site M Hgb Analyzer PackSTANBIO LABORATORY, L.P.KHG2016-09-24
00657498000151STAT-Site M Hgb CardsSTANBIO LABORATORY, L.P.KHG2016-09-24
00657498000175STAT-Site M Hgb Code KeySTANBIO LABORATORY, L.P.KHG2016-09-24
05391516743136Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
05391516743143Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
05391516743150Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
00811727011466Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDKHG2016-08-31
00811727011473Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDKHG2016-08-31