Pregnancy Check hCG Strip

GUDID 00852108007128

ALLSOURCE SCREENING SOLUTIONS, LLC

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00852108007128
• NIH Device Record Key: 8d57d7b3-0c10-442c-942c-ab02ec42f329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pregnancy Check hCG Strip
• Version Model Number: ALLHCGSR
• Company DUNS: 080358180
• Company Name: ALLSOURCE SCREENING SOLUTIONS, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852108007128 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-22

On-Brand Devices [Pregnancy Check hCG Strip]

• 00852108007135: ALLHCGSR
• 00852108007128: ALLHCGSR
• 00852108007111: ALLHCGSR