ARCHITECT 07K7610

GUDID 00380740014841

ARCHITECT Prolactin Controls

ABBOTT IRELAND

Prolactin IVD, control

• Primary Device ID: 00380740014841
• NIH Device Record Key: 7b2af6ec-c65c-4116-8288-28df748357b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 7K76-10
• Catalog Number: 07K7610
• Company DUNS: 989964119
• Company Name: ABBOTT IRELAND
• 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
• 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

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to the refrigerated storage (2 to 8 degrees C)
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at -20 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Handling Environment Temperature: Between 0 and -18 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740014841 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

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• 00380740129491: ARCHITECT Total T4 Reagent Kit (2000T)
• 00380740129484: ARCHITECT Total T4 Reagent Kit (100T)
• 00380740129460: ARCHITECT Total T4 Controls
• 00380740129453: ARCHITECT Total T4 Calibrators
• 00380740119812: ARCHITECT Free T4 Reagent Kit (500T)
• 00380740119805: ARCHITECT Free T4 Reagent Kit (2000T)
• 00380740119799: ARCHITECT Free T4 Reagent Kit (100T)
• 00380740117818: ARCHITECT 25-OH Vitamin D Reagent Kit (2000T)
• 00380740116446: ARCHITECT 25-OH Vitamin D Reagent Kit (500T)
• 00380740116439: ARCHITECT 25-OH Vitamin D Reagent Kit (100T)
• 00380740106065: ARCHITECT ESTRADIOL REAGENT KIT 1 x 500
• 00380740106058: ARCHITECT PROGESTERONE REAGENT KIT 1 x 500
• 00380740105990: ARCHITECT Prolactin Reagent Kit (500T)
• 00380740105983: ARCHITECT FSH Reagent Kit (500T)
• 00380740105976: ARCHITECT Ferritin Reagent Kit (500T)
• 00380740105969: ARCHITECT TSH Reagent Kit (500T)
• 00380740105952: ARCHITECT Total T4 Reagent Kit (500T)
• 00380740105945: ARCHITECT Total T3 Reagent Kit (500T)
• 00380740105938: ARCHITECT Free T4 Reagent Kit (500T)
• 00380740105921: ARCHITECT Free T3 Reagent Kit (500T)
• 00380740081126: ARCHITECT Free T4 Reagent Kit (100T)
• 00380740081065: ARCHITECT Free T4 Reagent Kit (2000T)
• 00380740081034: ARCHITECT Free T4 Calibrators
• 00380740014971: ARCHITECT Total Beta hCG Reagent Kit (2000T)
• 00380740014964: ARCHITECT Total Beta hCG Reagent Kit (100T)
• 00380740014940: ARCHITECT Total Beta hCG Controls
• 00380740014933: ARCHITECT Total Beta hCG Calibrators
• 00380740014926: ARCHITECT Progesterone Manual Diluent
• 00380740014919: ARCHITECT Progesterone Reagent Kit (100T)
• 00380740014896: ARCHITECT Progesterone Controls
• 00380740014889: ARCHITECT Progesterone Calibrators
• 00380740014865: ARCHITECT Prolactin Reagent Kit (100T)
• 00380740014841: ARCHITECT Prolactin Controls
• 00380740014834: ARCHITECT Prolactin Calibrators
• 00380740014810: ARCHITECT FSH Reagent Kit (100T)
• 00380740014797: ARCHITECT FSH Controls
• 00380740014780: ARCHITECT FSH Calibrators
• 00380740014728: ARCHITECT Estradiol Manual Diluent
• 00380740014711: ARCHITECT Estradiol Reagent Kit (100T)
• 00380740014698: ARCHITECT Estradiol Controls
• 00380740014681: ARCHITECT Estradiol Calibrators
• 00380740014445: ARCHITECT Total T4 Reagent Kit (2000T)
• 00380740014438: ARCHITECT Total T4 Reagent Kit (100T)
• 00380740014414: ARCHITECT Total T4 Controls
• 00380740014407: ARCHITECT Total T4 Calibrators
• 00380740014360: ARCHITECT Free T4 Controls
• 00380740014346: ARCHITECT Total T3 Manual Diluent