IBDX ASR PLATE SACCHAROMYCES

GUDID 07290019819097

IBDX ASR PLATE SACCHAROMYCES contains an immobilized glycan purified from saccharomyces cerevisiae that can be used to detect the presence of anti-saccharomyces cerevisiae polysaccharide antibodies. Analytical and performance characteristics are not established.

GLYCOMINDS DIAGNOSTICS (2014) LTD

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD

• Primary Device ID: 07290019819097
• NIH Device Record Key: d2df14ce-0999-47a3-8344-c5694bc0492c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IBDX ASR PLATE SACCHAROMYCES
• Version Model Number: S301100
• Company DUNS: 531861160
• Company Name: GLYCOMINDS DIAGNOSTICS (2014) LTD
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com
• Phone: 8057912094
• Email: office@glycominds.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019819097 [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 GLYCOMINDS DIAGNOSTICS (2014) LTD

• 07290019819066 - IBDX ASR PLATE CHITOBIOSIDE: 2023-07-24 IBDX ASR PLATE CHITOBIOSIDE contains an immobilized Chitobioside glycan that can be used to detect the presence of anti-Chitobio
• 07290019819073 - IBDX ASR PLATE LAMINARIBIOSIDE: 2023-07-24 IBDX ASR PLATE LAMINARIBIOSIDE contains an immobilized Laminaribioside glycan that can be used to detect the presence of anti-La
• 07290019819080 - IBDX ASR PLATE MANNOBIOSIDE: 2023-07-24 IBDX ASR PLATE MANOBIOSIDE contains an immobilized Manobioside glycan that can be used to detect the presence of anti-Manobiosid
• 07290019819097 - IBDX ASR PLATE SACCHAROMYCES: 2023-07-24IBDX ASR PLATE SACCHAROMYCES contains an immobilized glycan purified from saccharomyces cerevisiae that can be used to detect the presence of anti-saccharomyces cerevisiae polysaccharide antibodies. Analytical and performance characteristics are not established.
• 07290019819097 - IBDX ASR PLATE SACCHAROMYCES: 2023-07-24 IBDX ASR PLATE SACCHAROMYCES contains an immobilized glycan purified from saccharomyces cerevisiae that can be used to detect th