FDA.reportPublic FDA data

Hemotec Whole Blood Control Kit Large

Primary DI
00817869020311
Brand
Hemotec Whole Blood Control Kit Large
Company
ANALYTICAL CONTROL SYSTEMS INC
Model
SC-125, SC-126, H2O
Published
2019-07-24
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
JPASystem, Multipurpose For In Vitro Coagulation Studies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925340000COAGULATION CONTROL CONTAINING HEMOGLOBINAnalytical Control Systems, Inc.1993-03-23JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817869020311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817869020311008178690203118178690203110817869020311

GMDN Terms#

Term, Definition table
TermDefinition
Activated clotting time (ACT) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the activated clotting time (ACT) of a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
038232682
Device count
1
Kit
true
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
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
00817869020182Hemoglobin A2 Normal ControlHC-111HC-1112019-01-31
00817869020199Hemoglobin A2 Elevated ControlHC-111ELHC-111EL2019-01-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20763000558189CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
20763000558295RACTMEDTRONIC, INC.JPA2026-02-22
04987562499700Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
08426951011223HemosIL CL TriggersINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08426951326594HemosIL CL Rinse solutionINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793045476ACL TOP 970 CLINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793058322HemosIL CL Probe ConditionerINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
10812747018531Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
20812747018538Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
00630414639772Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00630414640563Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018893Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018916Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
04987562518654Automated Blood Coagulation Analyzer CS-5100SYSMEX CORPORATIONJPA2024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500SYSMEX CORPORATIONJPA2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONJPA2024-02-22
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