Biochrom Ultra Ninhydrin Kit 2L NC

GUDID 05056336800598

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. Product sold as 1 x 2L.

BIOCHROM LIMITED

Assay development analyte-specific reagent IVD

• Primary Device ID: 05056336800598
• NIH Device Record Key: b130c661-b7bc-4156-98ce-caa5cd251219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biochrom Ultra Ninhydrin Kit 2L NC
• Version Model Number: 80-6003-10
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056336800598 [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

Devices Manufactured by BIOCHROM LIMITED

• 05056336800192 - Bio30+ System Physio Accel: 2023-07-24 Ion exchange chromatography analyzer with lithium accelerated column, LED monitor, computer, autosampler and Openlab software
• 05056336800208 - Bio30+ Physio Accelerated: 2023-07-24 Ion exchange chromatography analyzer sold with lithium accelerated column and autosampler.
• 05056336800215 - Bio30+ Physio Accel W/O A/S: 2023-07-24 Ion exchange chromatography analyzer sold with lithium accelerated column.
• 05056336800222 - Bio30+ System Physio HP: 2023-07-24 Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab s
• 05056336800239 - Bio30+ Sys Physio HP EZ Nin: 2023-07-24 Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab soft
• 05056336800246 - Bio30+ Physio High Performance: 2023-07-24 Ion exchange chromatography analyzer sold with lithium high performance column and autosampler.
• 05056336800253 - Bio30+ Physio W/O A/S HP: 2023-07-24 Ion exchange chromatography analyzer sold with lithium high performance column.
• 05056336800260 - Bio30+ System Physio HR: 2023-07-24 Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab soft