GUDID 04719872782193

The PG0681 Detection Reagent is used for detection of the CYP2C19*2 (c.681 G>A) SNP.

PHARMIGENE, Inc.

Cytochrome P450 (CYP450) gene polymorphism IVD, reagent

• Primary Device ID: 04719872782193
• NIH Device Record Key: 4ccdda74-fdaf-4ab3-820f-5ad21f52ef19
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PG-0681A-024
• Company DUNS: 658637223
• Company Name: PHARMIGENE, Inc.
• 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: 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

Customer Support Contacts

• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com
• Phone: +886227985885
• Email: service@pharmigene.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872782193 [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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by PHARMIGENE, Inc.

• 04719872780014 - NA: 2023-06-22 The PGIC01 Detection Reagent is used for amplification of an internal control gene.
• 04719872780205 - NA: 2023-06-22 The PG1502 Detection Reagent is used for amplification of the HLA-B*1502 allele.
• 04719872780441 - NA: 2023-06-22 The PG5801 Detection Reagent is used for amplification of the HLA-B*5801 allele.
• 04719872780618 - NA: 2023-06-22 The PG5701 Detection Reagent is used for amplification of the HLA-B*5701 allele.
• 04719872780717 - NA: 2023-06-22 The PG3101 Detection Reagent is used for amplification of the HLA-A*3101 allele.
• 04719872780878 - NA: 2023-06-22 The PG27 Detection Reagent is used for amplification of the HLA-B*27 allele.
• 04719872781653 - NA: 2023-06-22 The PG1639 Detection Reagent is used for detection of the VKORC1-1639 (G>A) SNP.
• 04719872781691 - NA: 2023-06-22 The PG1075 Detection Reagent is used for detection of the CYP2C9*3 (c.1075 A>C) SNP.