Axis® Homocysteine EIA FHCY100

GUDID 05055845400015

The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The d

AXIS-SHIELD DIAGNOSTICS LIMITED

Homocysteine IVD, reagent

• Primary Device ID: 05055845400015
• NIH Device Record Key: 7b9542d0-ee61-4f74-9296-75043b177572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axis® Homocysteine EIA
• Version Model Number: FHCY100
• Catalog Number: FHCY100
• Company DUNS: 229062427
• Company Name: AXIS-SHIELD DIAGNOSTICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441382422000
• Email: MDL-AXD-Product-Support@alere.

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055845400015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980907

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-13

Devices Manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED

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• 05055845400015 - Axis® Homocysteine EIA: 2018-07-06The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The d
• 05055845400015 - Axis® Homocysteine EIA: 2018-07-06 The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human
• 05055845400022 - Axis-Shield Homocysteine Controls: 2018-07-06 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) EIA: 2018-07-06 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 UniCel: 2018-07-06 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 Homocysteine: 2018-07-06 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 Homocysteine: 2018-07-06 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 Homocysteine: 2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in