Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes B2A102

GUDID 00816068020047

For In Vitro Diagnostic Use. Advanced Instruments Total and Direct Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, one 25mL bottle of Sulfanilic Acid Solution, one 25mL bottle of 0.2N Hydrochloric Acid, one 50mg Sodium Nitrite Tablet and 100 Cuvettes.

ADVANCED INSTRUMENTS, INC.

Conjugated (direct) bilirubin IVD, kit, spectrophotometry

• Primary Device ID: 00816068020047
• NIH Device Record Key: 7f114b5a-0380-4aea-8e32-508e349cd6c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes
• Version Model Number: B2A102
• Catalog Number: B2A102
• Company DUNS: 125006353
• Company Name: ADVANCED INSTRUMENTS, 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816068020047 [Primary]

FDA Product Code

• CIG: Diazo Colorimetry, Bilirubin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

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