Dimension Vista® Flex® reagent cartridge AST K2041

GUDID 00842768015595

Aspartate Aminotransferase Flex® reagent cartridge, 1600 tests

Siemens Healthcare Diagnostics Inc.

Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

• Primary Device ID: 00842768015595
• NIH Device Record Key: de9ddfa7-17cf-4579-b261-7f3fc48ec861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dimension Vista® Flex® reagent cartridge AST
• Version Model Number: 10445148
• Catalog Number: K2041
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	00630414005140 [Unit of Use]
GS1	00842768015595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061020

FDA Product Code

• CIT: Nadh oxidation/nad reduction, ast/sgot

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: 2016-09-24

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