HemosIL AcuStar Anti-B2 Glycoprotein-I IgG 0009802012

GUDID 08426950496977

HemosIL AcuStar Anti-B2 Glycoprotein-I IgG

INSTRUMENTATION LABORATORY COMPANY

Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID08426950496977
NIH Device Record Keya6ec937e-4975-4f50-806f-60dd14af0eff
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemosIL AcuStar Anti-B2 Glycoprotein-I IgG
Version Model Number0009802012
Catalog Number0009802012
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 Kitfalse
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
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950496977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSVSystem,test,antibodies,b2 - glycoprotein i (b2 - gpi)

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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