FDA.report

HemosIL Low Fibrinogen Control

Primary DI
08426950451976
Brand
HemosIL Low Fibrinogen Control
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00020004200
Catalog number
00020004200
Device description
HemosIL Low Fibrinogen Control
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KQJSystem, Fibrinogen Determination

Product Code Classifications

CodeDeviceSpecialtyClass
KQJSystem, Fibrinogen DeterminationHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950451976PrimaryGS10
18426950451973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950451976084269504519768426950451976
1842695045197318426950451973

GMDN Terms

TermDefinition
Fibrinogen assay (factor I) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Unopened control is stable until the expiration date shown on the vial when stored at 2-8°C.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags

DUNS number
557223252
Device count
10
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

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00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)000774450082023-10-02

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