FDA.reportPublic FDA data

QuikCoag Control Level 3 High Abnormal

Primary DI
00627944000080
Brand
QuikCoag Control Level 3 High Abnormal
Company
Biomedica Diagnostics Inc
Model
1 mL
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GGNPlasma, Coagulation Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022046000VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROLVital Scientific N.V.2002-07-23GGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627944000087PackageGS110In Commercial Distribution
00627944000080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062794400008710627944000087
00627944000080006279440000806279440000800627944000080

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
200152713
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627944000035QuikCoag PT-HS10 mL2016-09-22
00627944000066QuikCoag Control Level 1 Normal1 mL2016-09-22
00627944000073QuikCoag Control Level 2 Low Abnormal1 mL2016-09-22
00627944000097QuikCoag Calcium Chloride 0.02M4 mL2016-09-22
00627944000103QuikCoag Calcium Choride 0.02M10 mL2016-09-22
00627944000011QuikCoag PT-HS2 mL2016-09-22
00627944000028QuikCoag PT-HS4 mL2016-09-22
10627944000032QuikCoag PT-HS10 mL2016-09-22
00627944000042QuikCoag APTT-EA4 mL2016-09-22
00627944000059QuikCoag APTT-EA10 mL2016-09-22
10627944000063QuikCoag Control Level 1 Normal1 mL2016-09-22
10627944000070QuikCoag Control Level 2 Low Abnormal1 mL2016-09-22
10627944000087QuikCoag Control Level 3 High Abnormal1 mL2016-09-22
10627944000094QuikCoag Calcium Chloride 0.02M4 mL2016-09-22
10627944000100QuikCoag Calcium Choride 0.02M10 mL2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
050700024203855-PLASMA Bivalirudin Control5-Diagnostics LtdGGN2026-04-02
08426951011131HemosIL CL Multi-Ab ControlsINSTRUMENTATION LABORATORY COMPANYGGN2025-10-30
00815696021327George King Heparin Control Plasma GEORGE KING BIO-MEDICAL, INCGGN2025-07-11
08718734962724CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962731CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962748CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962755CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962762CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962779CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962786CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962793CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962809CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962816CueSee® CoagEurotrol B.V.GGN2025-04-08
09360136000055Xprecia™ Systems PT ControlsUNIVERSAL BIOSENSORS PTY LTDGGN2024-08-27
08430793242998HEMOSIL RIVAROXABAN CONTROLSINSTRUMENTATION LABORATORY COMPANYGGN2024-07-22
00630414639840INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639857INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639949INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639956INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640624ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229522INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229546INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229515INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229539INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019463Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019456Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019005ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640747Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19