FDA.reportPublic FDA data

Calcium chloride 0.025M (M/40)

Primary DI
03663537084768
Brand
Calcium chloride 0.025M (M/40)
Company
HYPHEN BIOMED
Model
AR001B
Catalog number
AR001B
Published
2020-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663537084768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663537084768036635370847683663537084768

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
503499167
Device count
1
Premarket exempt
true
Kit
true
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
03663537084782Calcium chloride 0.025M (M/40)AR001LAR001L2020-11-16
03663537008320BIOPHEN™ V-L Control Plasma 2234052234052016-08-25
03663537019074BIOPHEN™ V-L Plasma Calibrator2224012224012016-08-25
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