ARCHITECT 03L5202

GUDID 00380740082116

ARCHITECT 25-OH Vitamin D Calibrators

Abbott GmbH & Co. KG

Multiple vitamin IVD, calibrator

• Primary Device ID: 00380740082116
• NIH Device Record Key: 07d62beb-721e-4eac-9a96-a35132289241
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 3L52-02
• Catalog Number: 03L5202
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740082116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110619

FDA Product Code

• MRG: SYSTEM, TEST, VITAMIN D

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: 2016-09-09

On-Brand Devices [ARCHITECT]

• 00380740156527: ARCHITECT Homocysteine Reagent Kit
• 00380740150907: Alkaline Phosphatase
• 00380740150891: Alkaline Phosphatase
• 00380740145408: ARCHITECT CA19-9XR Controls
• 00380740145392: ARCHITECT CA19-9XR Calibrators
• 00380740145385: ARCHITECT CA 125 II Reagent Kit
• 00380740145378: ARCHITECT CA 125 II Reagent Kit
• 00380740145361: ARCHITECT CA 125 II Reagent Kit
• 00380740145354: ARCHITECT CA 125 II Controls
• 00380740145347: ARCHITECT CA 125 II Calibrators
• 00380740145330: ARCHITECT CA 15-3 Reagent Kit
• 00380740145323: ARCHITECT CA 15-3 Reagent Kit
• 00380740145316: ARCHITECT CA 15-3 Reagent Kit
• 00380740145309: ARCHITECT CA 15-3 Controls
• 00380740145293: ARCHITECT CA 15-3 Calibrators
• 00380740145286: ARCHITECT BNP Reagent Kit
• 00380740145279: ARCHITECT BNP Reagent Kit
• 00380740145262: ARCHITECT BNP Controls
• 00380740145255: ARCHITECT BNP Calibrators
• 00380740139049: ARCHITECT B.R.A.H.M.S PCT Reagent Kit
• 00380740139032: ARCHITECT B.R.A.H.M.S PCT Reagent Kit
• 00380740138912: ARCHITECT B.R.A.H.M.S PCT Controls
• 00380740138905: ARCHITECT B.R.A.H.M.S PCT Calibrators
• 00380740137304: ARCHITECT CA19-9XR Reagent Kit
• 00380740129040: Total Bilirubin
• 00380740129033: Total Bilirubin
• 00380740119416: Microalbumin
• 00380740119409: Microalbumin Controls
• 00380740119393: Microalbumin Calibrators
• 00380740117122: ARCHITECT Syphilis TP Reagent Kit
• 00380740117115: ARCHITECT Syphilis TP Reagent Kit
• 00380740112776: ARCHITECT Intact PTH Controls
• 00380740112769: ARCHITECT Intact PTH Calibrators
• 00380740105327: ARCHITECT iVancomycin Reagent Kit
• 00380740103545: ARCHITECT Syphilis TP Controls
• 00380740103538: ARCHITECT Syphilis TP Calibrator
• 00380740099473: ARCHITECT 2nd Generation Testosterone Reagent Kit
• 00380740096618: ARCHITECT Galectin-3 Reagent Kit
• 00380740096144: ARCHITECT Galectin-3 Controls
• 00380740096137: ARCHITECT Galectin-3 Calibrators
• 00380740082147: ARCHITECT 25-OH Vitamin D Reagent Kit
• 00380740082130: ARCHITECT 25-OH Vitamin D Reagent Kit
• 00380740082123: ARCHITECT 25-OH Vitamin D Controls
• 00380740082116: ARCHITECT 25-OH Vitamin D Calibrators
• 00380740081935: ARCHITECT iCarbamazepine Calibrator A Multi-Pack
• 00380740081072: ARCHITECT iCarbamazepine Reagent Kit
• 00380740048471: ARCHITECT Intact PTH Reagent Kit
• 00380740048433: ARCHITECT HE4 Reagent Kit
• 00380740017453: ARCHITECT DHEA-S Reagent Kit
• 00380740017439: ARCHITECT DHEA-S Controls