Alinity 09P4140

GUDID 00380740154233

Alinity i Sirolimus Whole Blood Precipitation Reagent 1 Tests

ABBOTT LABORATORIES

Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent

• Primary Device ID: 00380740154233
• NIH Device Record Key: 3b65fe66-55ce-499f-a585-a05f1c601d02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity
• Version Model Number: 09P4140
• Catalog Number: 09P4140
• 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
• 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740154233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070822

FDA Product Code

• NRP: Sirolimus test system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-13
• Device Publish Date: 2020-05-05

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• 00380740156848: Alinity c-series Reagent Cartridge, Clear (Large)
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• 00380740156824: Alinity i Maintenance Cleaning Cartridge
• 00380740154295: Alinity c Clinical Chemistry Calibrator Kit
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• 00380740154110: Alinity c Phenobarbital Reagent Kit 200 Tests
• 00380740154103: Alinity c Amikacin Reagent Kit 200 Tests
• 00380740153755: Alinity c ASO Control II
• 00380740153748: Alinity c ASO Control I
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• 00380740153717: Alinity c Proteins Calibrators
• 00380740153601: Alinity c B2-Microglobulin Reagent Kit 200 Tests
• 00380740153588: Alinity c B2-Microglobulin Calibrator
• 00380740153564: Alinity c ASO Reagent Kit 300 Tests
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• 00380740136192: Alinity c Ammonia Ultra Reagent Kit
• 00380740136185: Alinity c Ammonia Controls
• 00380740136178: Alinity c Creatinine (Enzymatic) Reagent Kit 3600 Tests
• 00380740136161: Alinity c Creatinine (Enzymatic) Reagent Kit 1440 Tests
• 00380740135614: Alinity c Salicylate Reagent Kit 200 Tests
• 00380740135607: Alinity c Salicylate Calibrator Kit
• 00380740135522: Alinity c Gentamicin Reagent Kit 200 Tests
• 00380740135515: Alinity c Phenytoin Reagent Kit 400 Tests
• 00380740135386: Alinity c Ethanol Reagent Kit 200 Tests
• 00380740135379: Alinity c Ethanol Control Kit
• 00380740135355: Alinity c Ethanol Calibrator Kit
• 00380740135348: Alinity c Vancomycin Reagent Kit 400 Tests
• 00380740135324: Alinity c Digoxin Reagent Kit 800 Tests
• 00380740129972: Alinity c Direct LDL Reagent Kit
• 00380740121891: Alinity c UIBC Reagent Kit 300 Tests
• 00380740153809: Alinity c A-1-AGP Reagent Kit 200 Tests
• 00380740135393: Alinity c Ethanol Reagent Kit 400 Tests
• 00380740153847: Alinity c Lp(a) Reagent Kit 200 Tests
• 00380740153823: Alinity c Lp(a) Control Kit
• 00380740153816: Alinity c Lp(a) Calibrators
• 00380740151317: Alinity c Plasmaproteins Cal 3x Kit
• 00380740174880: Alinity c DOA MC Negative Calibrator Kit
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• 00380740165529: Alinity c DOA MC Semiquant Calibrator Kit
• 00380740165512: Alinity c DOA MC Qual Calibrator 2 Kit
• 00380740165345: Alinity c DOA MC III Controls
• 00380740165321: Alinity c DOA MC I Controls