HAEM CNTL - LEVEL 1, 2, 3 HM5162

GUDID 05055273210200

This product is intended for in vitro diagnostic use in the quality control of multiple haematology parameters

RANDOX LABORATORIES LIMITED

Full blood count IVD, control

• Primary Device ID: 05055273210200
• NIH Device Record Key: c20a35d5-cf06-4aa7-b92b-aab034afac84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEM CNTL - LEVEL 1, 2, 3
• Version Model Number: HM5162
• Catalog Number: HM5162
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES 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: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not allow tubes to overheat or freeze. Store tubes upright. Opened tubes are stable for 14 days when stored upright at 2-8°C
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273210200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913879

FDA Product Code

• JPK: Mixture, Hematology Quality Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

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