Arvolife

GUDID 10851950008137

Clinical Guard

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10851950008137
• NIH Device Record Key: ae844af2-0ff2-46e9-ba49-4ab14bfa4faf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arvolife
• Version Model Number: HCG Midstream
• Company DUNS: 827033924
• Company Name: Clinical Guard
• Device Count: 3
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851950008055 [Unit of Use]
GS1	00851950008130 [Primary]
GS1	10851950008137 [Package]; Contains: 00851950008130; Package: [150 Units]; In Commercial Distribution

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2018-04-27
• Device Publish Date: 2018-03-27

On-Brand Devices [Arvolife]

• 00851950008154: Drug Test Cup
• 00851950008147: Drug Test Panel
• 10851950008137: HCG Midstream
• 00851950008123: THC Marijuana Drug Test Strip
• 10851950008045: 50 Ovulation Tests and 20 Pregnancy Tests Comb Kit