Axis-Shield Homocysteine Controls FHCY200

GUDID 05055845400022

The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of tota

AXIS-SHIELD DIAGNOSTICS LIMITED

Homocysteine IVD, control
Primary Device ID05055845400022
NIH Device Record Key4f971af8-835d-4596-b55a-faba4cd1e822
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxis-Shield Homocysteine Controls
Version Model NumberFHCY200
Catalog NumberFHCY200
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
GS105055845400022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

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

Devices Manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED

05055845400008 - Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptid2018-07-06 The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of
05055845400015 - Axis® Homocysteine EIA2018-07-06 The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human
05055845400022 - Axis-Shield Homocysteine Controls2018-07-06The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of tota
05055845400022 - Axis-Shield Homocysteine Controls2018-07-06 The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitati
05055845400046 - Axis-Shield Active-B12 (Holotranscobalamin) EIA2018-07-06 The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holot
05055845400084 - 3-Reagent Homocysteine Assay for SYNCHRON UniCel2018-07-06 The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total hom
05055845400169 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in
05055845400176 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in
05055845400183 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in

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