ARCHITECT 02K9821

GUDID 00380740119416

Microalbumin

Abbott GmbH & Co. KG

Microalbumin IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00380740119416
• NIH Device Record Key: 68ef8eca-9ff4-4d39-9609-631858d6752e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 2K98-21
• Catalog Number: 02K9821
• 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: 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: +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
• 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 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 Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Handling 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
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740119416 [Primary]

FDA Product Code

• JIQ: TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

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: 2017-01-31

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