Rite Aid

GUDID 00011822887021

RITE AID +/- PREGNANCY TEST KI

RITE AID CORPORATION

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

• Primary Device ID: 00011822887021
• NIH Device Record Key: d75dc947-65e5-4a99-a7be-8b3777a4b2ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rite Aid
• Version Model Number: 8025009
• Company DUNS: 014578892
• Company Name: RITE AID CORPORATION
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00011822887021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123050

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: 2023-02-16
• Device Publish Date: 2023-02-08

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• 00011822887038: RITE AID +/- PREG TST 3CT
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• 00011822887045: RA EARLY RSLT PREG TST 3CT
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