FDA.reportPublic FDA data

QuikCoag Calcium Chloride 0.02M

Primary DI
00627944000097
Brand
QuikCoag Calcium Chloride 0.02M
Company
Biomedica Diagnostics Inc
Model
4 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
GFOActivated Partial Thromboplastin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFOActivated Partial ThromboplastinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022021000VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTVital Scientific N.V.2002-11-01GFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627944000094PackageGS110In Commercial Distribution
00627944000097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062794400009410627944000094
00627944000097006279440000976279440000970627944000097

GMDN Terms#

Term, Definition table
TermDefinition
Calcium chloride coagulation reagent IVDA calcium chloride solution intended to be used alone or in combination with other IVDs in the performance of coagulation tests or other laboratory investigations of clinical specimens.

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
00627944000080QuikCoag Control Level 3 High Abnormal1 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
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00630414640709Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640716Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00842768019579Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00842768019074Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00850053916199IDG/SanzayIDG/SANZAY CorporationGFO2024-01-12
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00817869020014Slide Platelet Aggregation Test ReagentANALYTICAL CONTROL SYSTEMS INCGFO2019-01-31
00842768003837Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768003851Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768007521Pathromtin® SLSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768007538Pathromtin® SLSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
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08426950078937HemosIL APTT-SPINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
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00627944000103QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
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00627944000059QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
10627944000094QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
10627944000100QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00845275000511Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16
00845275000641Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16