Pointe Scientific HA926-504

GUDID 00811727012883

ALT reagent for the quantitative determination of alanine aminotransferase in serum on Hitachi analyzers. For in vitro diagnostic use only. 6 x 67ml, 6 x 17ml

POINTE SCIENTIFIC, INC.

Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent

• Primary Device ID: 00811727012883
• NIH Device Record Key: 02942c84-5c5f-45f5-ba8e-b500633cbf0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Scientific
• Version Model Number: HA926-504
• Catalog Number: HA926-504
• 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

Customer Support Contacts

• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com

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	00811727012883 [Primary]

FDA Product Code

• CKA: Nadh Oxidation/Nad Reduction, Alt/Sgpt

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: 2016-08-31

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