Axis-Shield Liquid Stable (LS) 2-Part Homocysteine FHRWR100

GUDID 05055845400169

The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma

AXIS-SHIELD DIAGNOSTICS LIMITED

Homocysteine IVD, reagent
Primary Device ID05055845400169
NIH Device Record Key9f0cd5a6-17f2-4978-8f6c-953710ec3e5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxis-Shield Liquid Stable (LS) 2-Part Homocysteine
Version Model NumberFHRWR100
Catalog NumberFHRWR100
Company DUNS229062427
Company NameAXIS-SHIELD DIAGNOSTICS LIMITED
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

Phone+441382422000
EmailMDL-AXD-Product-Support@alere.
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055845400169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-01

On-Brand Devices [Axis-Shield Liquid Stable (LS) 2-Part Homocysteine]

05055845400282The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determi
05055845400183The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determi
05055845400176The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determi
05055845400169The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determi

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