FDA.reportPublic FDA data

QuikCoag Calcium Choride 0.02M

Primary DI
10627944000100
Brand
QuikCoag Calcium Choride 0.02M
Company
Biomedica Diagnostics Inc
Model
10 mL
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10627944000100PackageGS110In Commercial Distribution
00627944000103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062794400010010627944000100
00627944000103006279440001036279440001030627944000103

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
200152713
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414640310Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640334Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
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
00843876000596CRYOcheck Hex LAPrecision Biologic IncGFO2023-05-02
00843876000510CRYOcheck Hex LA Precision Biologic IncGFO2020-11-05
00843876000527CRYOcheck Hex LAPrecision Biologic IncGFO2020-11-05
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
08426950087649HemosIL SynthAFaxINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950433491HemosIL Silica Clotting TimeINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950023487HemosIL Calcium Chloride 0.025M (for APTT-SP kit)INSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950078920HemosIL SynthASilINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950078937HemosIL APTT-SPINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950915676GEM TEST APTT CITRATEINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950087632HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)INSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
00627944000097QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00627944000103QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
10711234103029Hemochron Whole Blood Microcoagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.GFO2016-09-22
00627944000042QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
00627944000059QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
10627944000094QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00845275000511Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16
00845275000641Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16