HemosIL AcuStar D-Dimer 0009802000

GUDID 08426950496946

HemosIL AcuStar D-Dimer

INSTRUMENTATION LABORATORY COMPANY

D-dimer IVD, kit, agglutination
Primary Device ID08426950496946
NIH Device Record Key78c7189b-c255-46e2-a6c9-34db1dbe00aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemosIL AcuStar D-Dimer
Version Model Number0009802000
Catalog Number0009802000
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950496946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-07-08
Device Publish Date2016-09-23

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