FDA.reportPublic FDA data

QuikCoag PT-HS

Primary DI
00627944000028
Brand
QuikCoag PT-HS
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
GJSTest, Time, Prothrombin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020840000VITAL SCIENTIFIC PT WITH CALCIUMVital Scientific N.V.2002-05-15GJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627944000025PackageGS110In Commercial Distribution
00627944000028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062794400002510627944000025
00627944000028006279440000286279440000280627944000028

GMDN Terms#

Term, Definition table
TermDefinition
Prothrombin time (PT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).

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
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
00627944000097QuikCoag Calcium Chloride 0.02M4 mL2016-09-22
00627944000103QuikCoag Calcium Choride 0.02M10 mL2016-09-22
00627944000011QuikCoag PT-HS2 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

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