CELL-DYN 09H7201

GUDID 00380740119829

CELL-DYN 22 Plus Control

ABBOTT LABORATORIES

Full blood count IVD, control

• Primary Device ID: 00380740119829
• NIH Device Record Key: 423072a6-3e4d-4ffd-bebe-b458637be094
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELL-DYN
• Version Model Number: 09H72-01
• Catalog Number: 09H7201
• Company DUNS: 079226220
• Company Name: ABBOTT LABORATORIES
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740119829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111211

FDA Product Code

• GLQ: MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES

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 [CELL-DYN]

• 00380740020996: CELL-DYN 1800 System DETERGENT
• 00380740001148: CELL-DYN Sapphire System WBC REAGENT - PART B
• 00380740001131: CELL-DYN Sapphire System WBC REAGENT - PART A
• 00380740120788: CELL-DYN Emerald 22 Diluent
• 00380740120771: CELL-DYN Emerald 22 Lyse
• 00380740120764: CELL-DYN Emerald 22 Easy Cleaner
• 00380740119843: CELL-DYN 22 Plus Calibrator
• 00380740119836: CELL-DYN 22 Plus Control
• 00380740119829: CELL-DYN 22 Plus Control
• 00380740099916: CELL-DYN Ruby
• 00380740072643: CELL-DYN 1800 System CN-FREE DIFF LYSE
• 00380740072445: CELL-DYN 1800 System DILUENT
• 00380740071141: CELL-DYN 1800
• 00380740021085: ENZYM CLNR 2X50 ML
• 00380740021016: CELL-DYN 3700 System HGB / WIC LYSE
• 00380740020989: CELL-DYN 3700 System DETERGENT
• 00380740020972: CELL-DYN 1800 System DETERGENT
• 00380740020965: CELL-DYN 3700 SHEATH
• 00380740020958: CELL-DYN 3700 System DILUENT
• 00380740020941: CELL-DYN 1800 System DILUENT
• 00380740020347: CELL-DYN 18 PLUS CALIBRATOR
• 00380740020330: CELL-DYN 18 PLUS CONTROL
• 00380740020323: CELL-DYN 18 PLUS CONTROL
• 00380740020286: CELL-DYN EMERALD 22
• 00380740020156: CELL-DYN Emerald DILUENT
• 00380740020149: CELL-DYN Emerald CN-FREE LYSE
• 00380740020132: CELL-DYN Emerald CLEANER
• 00380740020088: CELL-DYN Emerald
• 00380740017170: CELL-DYN Ruby
• 00380740017149: CELL-DYN RETIC PLUS CONTROL
• 00380740017118: CELL-DYN 26 PLUS CONTROL
• 00380740017101: CELL-DYN 26 PLUS CONTROL
• 00380740017095: CELL-DYN 29 PLUS CONTROL (with Retic)
• 00380740017088: CELL-DYN 29 PLUS CONTROL (with Retic)
• 00380740017071: CELL-DYN HemCal Plus Calibrator
• 00380740017026: CELL-DYN Ruby, CELL-DYN 3200 Systems WBC LYSE
• 00380740016623: CELL-DYN Sapphire
• 00380740016616: CELL-DYN Sapphire
• 00380740013547: CELL-DYN 1800 System CN-FREE DIFF LYSE
• 00380740013493: CELL-DYN 1800
• 00380740013356: CELL-DYN Immuno T-Cell (CD3/4/8) Reagents
• 00380740007317: CELL-DYN 3200
• 00380740007300: CELL-DYN 3200
• 00380740007270: CELL-DYN 3200
• 00380740007263: CELL-DYN 3200
• 00380740005160: CELL-DYN Ruby, CELL-DYN 3200 System CN-FREE HGB/NOC LYSE
• 00380740005153: CELL-DYN 3200 System DILUENT/SHEATH
• 00380740005146: CELL-DYN 3200 WBC LYSE
• 00380740005115: CELL-DYN 3700 System CN-FREE HGB / WIC LYSE
• 00380740005009: CELL-DYN RETICULOCYTE REAGENT