DHEA HYE-5346

GUDID 00840239053466

The DRG:Hybrid-XL DHEA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA in serum and plasma.

DRG International Inc

Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA) Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239053466
• NIH Device Record Key: f67450e2-bd40-445e-b130-aa94b81ca223
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DHEA
• Version Model Number: HYE-5346
• Catalog Number: HYE-5346
• Company DUNS: 075150847
• Company Name: DRG International 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 973-564-7555
• Email: corpoffice@drg-international.com
• Phone: 1 973-564-7555
• Email: corpoffice@drg-international.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239053466 [Primary]

FDA Product Code

• JKC: Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

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: 2023-09-04
• Device Publish Date: 2023-08-26

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