Biochrom EZ Nin reagent (2L) NC

GUDID 05056336801052

Reagent is designed to give a color reaction with any primary or secondary amino acid, in addition to some amines. This product is an Analyte Specific Reagent. Analytical and performance characteristics are not established. The Analyte Specific Reagent is intended to be used as a component of an in-house developed test used exclusively by laboratories.

BIOCHROM LIMITED

Assay development analyte-specific reagent IVD

• Primary Device ID: 05056336801052
• NIH Device Record Key: 623347ad-f0f5-40e7-ae48-df8cd170b888
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biochrom EZ Nin reagent (2L) NC
• Version Model Number: 80-6003-19
• Company DUNS: 235280646
• Company Name: BIOCHROM LIMITED
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056336801052 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2023-07-24
• Device Publish Date: 2023-07-14

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