Pointe Scientific HB936-120

GUDID 00811727012937

Direct Bilirubin reagent for the quantitative determination of direct bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. 5 x 18ml, 5 x 6ml

POINTE SCIENTIFIC, INC.

Conjugated (direct) bilirubin IVD, reagent

• Primary Device ID: 00811727012937
• NIH Device Record Key: 8113884b-ea41-4dc2-aca8-03ae0a5273ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Scientific
• Version Model Number: HB936-120
• Catalog Number: HB936-120
• Company DUNS: 045623154
• Company Name: POINTE SCIENTIFIC, INC.
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727012937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040391

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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