ARCHITECT 06P2210

GUDID 00380740138912

ARCHITECT B.R.A.H.M.S PCT Controls

Abbott GmbH & Co. KG

Procalcitonin (PCT) IVD, calibrator

• Primary Device ID: 00380740138912
• NIH Device Record Key: b3dad55c-25e4-4b71-9ab8-cc0c956f1da7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 06P2210
• Catalog Number: 06P2210
• Company DUNS: 315786293
• Company Name: Abbott GmbH & Co. KG
• 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: true
• 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: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740138912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170652

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: 2017-08-16

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