i-STAT hs-TnI Control Level 2 06P17-22

GUDID 00054749004935

i-STAT hs-TnI Control Level 2

Abbott Point of Care Inc.

Troponin I IVD, control

• Primary Device ID: 00054749004935
• NIH Device Record Key: 20d67fed-31ca-48b0-8a7f-d1c060daeb1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-STAT hs-TnI Control Level 2
• Version Model Number: 06P17-22
• Catalog Number: 06P17-22
• Company DUNS: 116279183
• Company Name: Abbott Point of Care Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00054749004935 [Primary]

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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: 2025-05-12
• Device Publish Date: 2025-05-02

Devices Manufactured by Abbott Point of Care Inc.

• 00054749004911 - i-STAT hs-TnI Calibration Verification, Levels 1-3: 2025-05-12 i-STAT hs-TnI Calibration Verification, Levels 1-3
• 00054749004928 - i-STAT hs-TnI Control Level 1: 2025-05-12 i-STAT hs-TnI Control Level 1
• 00054749004935 - i-STAT hs-TnI Control Level 2: 2025-05-12i-STAT hs-TnI Control Level 2
• 00054749004935 - i-STAT hs-TnI Control Level 2: 2025-05-12 i-STAT hs-TnI Control Level 2
• 00054749004942 - i-STAT hs-TnI Control Level 3: 2025-05-12 i-STAT hs-TnI Control Level 3
• 00054749003051 - i-STAT hs-TnI cartridge: 2025-05-07 i-STAT hs-TnI cartridge
• 00054749005772 - i-STAT TBI cartridge: 2024-07-16 i-STAT TBI cartridge
• 10054749005717 - i-STAT G Cartridge: 2024-05-08 i-STAT G Cartridge
• 10054749005670 - i-STAT G3+ Cartridge: 2023-12-26 For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2