STAT-Site M B-HB Analyzer Pack 400400

GUDID 00657498000083

The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.

STANBIO LABORATORY, L.P.

Single-channel clinical chemistry analyser IVD, point-of-care Single-channel clinical chemistry analyser IVD, point-of-care

• Primary Device ID: 00657498000083
• NIH Device Record Key: 24fbd61c-cc95-43f2-b880-914d73093aff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAT-Site M B-HB Analyzer Pack
• Version Model Number: 400400
• Catalog Number: 400400
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498000083 [Primary]

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2018-04-16
• Device Publish Date: 2016-09-24

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