Healgen GBTHC-101a

GUDID 20816490023542

Single Panel DOA Test Strip

Healgen Scientific Limited Liability Company

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 20816490023542
• NIH Device Record Key: bcccf213-e2e5-4822-a6c5-7a7ce6cab468
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healgen
• Version Model Number: GBTHC-101a
• Catalog Number: GBTHC-101a
• Company DUNS: 031802328
• Company Name: Healgen Scientific Limited Liability Company
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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: true

Customer Support Contacts

• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com
• Phone: 7137338088
• Email: bryan@healgen.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816490023548 [Primary]
GS1	10816490023545 [Package]; Contains: 00816490023548; Package: Inner Pack [100 Units]; In Commercial Distribution
GS1	20816490023542 [Package]; Contains: 10816490023545; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

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: 2019-08-09
• Device Publish Date: 2019-08-01

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