TDM CAL TD3417

GUDID 05055273206470

This product is intended for use in the calibration of therapeutic drug assays.

RANDOX LABORATORIES LIMITED

Multiple-therapy therapeutic drug monitoring IVD, calibrator

• Primary Device ID: 05055273206470
• NIH Device Record Key: c8a258f7-cd97-4127-958a-a3d55bcbfd93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TDM CAL
• Version Model Number: TD3417
• Catalog Number: TD3417
• 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: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273206470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012318

FDA Product Code

• DKB: Calibrators, Drug Mixture

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: 2016-09-24

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