FDA.reportPublic FDA data

Animal Plasma Control Level II

Primary DI
00817869020243
Brand
Animal Plasma Control Level II
Company
ANALYTICAL CONTROL SYSTEMS INC
Model
SC-113
Catalog number
SC-113
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
GGCControl, Plasma, Abnormal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGCControl, Plasma, AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893971000ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIAnalytical Control Systems, Inc.1989-07-25GGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817869020243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817869020243008178690202438178690202430817869020243

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
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
00817869020182Hemoglobin A2 Normal ControlHC-111HC-1112019-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198815000107Recombinant Factor VIII Substrate, Porcine SequenceTakeda Pharmaceuticals U.S.A., Inc.GGC2025-08-01
00630414640013LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640099LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019678LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019685LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640167Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00842768019470Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00630414639703Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00842768018589Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00815696021341George King SysCOR-40 Control KitGEORGE KING BIO-MEDICAL, INCGGC2023-03-15
00815696021143George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00815696021150George King Factor XIII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00815696021112George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2018-06-22
00815696021051George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00815696021068George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00630414023502LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
00630414023519LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006108LupoTek Detectin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006115LupoTek Correctin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006122PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006139PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
00842768004056Dade® Ci-Trol® Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006838Berichrom® Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006852Berichrom® Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008351LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008368LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768011580Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24