FDA.reportPublic FDA data

BIOPHEN™ V-L Plasma Calibrator

Primary DI
03663537019074
Brand
BIOPHEN™ V-L Plasma Calibrator
Company
HYPHEN BIOMED
Model
222401
Catalog number
222401
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083729000HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHENAniara Diagnostica, LLC2009-05-08GGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663537019074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663537019074036635370190743663537019074

GMDN Terms#

Term, Definition table
TermDefinition
Activated protein C resistant factor V (factor V Leiden) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of factor V Leiden, a clotting protein resistant to cleavage by activated protein C, in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
503499167
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663537008306BIOPHEN NORMAL CONTROL PLASMA2232012232012016-08-25
03663537008313BIOPHEN ABNORMAL CONTROL PLASMA2233012233012016-08-25
03663537008221BIOPHEN Protein C 2.52212022212022016-08-25
03663537008047Imidazole bufferAR021AAR021A2020-06-30
03663537008450Calcium chloride 0.025M (M/40)AR001AAR001A2020-06-30
03663537008474Calcium chloride 0.25M (M/4)AR002AAR002A2020-06-30
03663537008481Calcium chloride 0.25M (M/4)AR002KAR002K2020-06-30
03663537084805Imidazole bufferAR021B2020-10-28
03663537084829Imidazole bufferAR021M2020-10-28
03663537084843Imidazole bufferAR021N2020-10-28
03663537010439Imidazole bufferAR021KAR021K2020-06-30
03663537010446Imidazole bufferAR021LAR021L2020-06-30
03663537084768Calcium chloride 0.025M (M/40)AR001BAR001B2020-11-16
03663537084782Calcium chloride 0.025M (M/40)AR001LAR001L2020-11-16
03663537008320BIOPHEN™ V-L Control Plasma 2234052234052016-08-25
03663537008467Calcium chloride 0.025M (M/40)AR001K2020-06-30
03663537007989BIOPHEN LMWH Control C32238012238012016-08-25
03663537007996BIOPHEN UFH CONTROL C22239012239012016-08-25
03663537008184BIOPHEN HEPARIN 32210032210032016-08-25
03663537008191BIOPHEN HEPARIN 62210062210062017-03-08

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