Axis-Shield Liquid Stable (LS) 2-Part Homocysteine FHBC100/B08176

GUDID 05055845400282

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 ID: 05055845400282
• NIH Device Record Key: 1a8693aa-ef0c-4932-8b27-3e4c588aaa91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine
• Version Model Number: FHBC100/B08176
• Catalog Number: FHBC100/B08176
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055845400282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083222

FDA Product Code

• JIT: Calibrator, Secondary

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: 2016-07-01

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

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