Am I Pregnant?

GUDID 00722355002842

Home pregnancy test for early results

IMMUNOSTICS COMPANY, INC

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

• Primary Device ID: 00722355002842
• NIH Device Record Key: 3156d76c-1c4d-4ed5-aec7-dcd21fb034f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Am I Pregnant?
• Version Model Number: 5050M2-1B
• Company DUNS: 119214195
• Company Name: IMMUNOSTICS COMPANY, INC
• 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: true

Customer Support Contacts

• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com
• Phone: +1(856)727-0008
• Email: info@acandcdistribution.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00722355002842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960174

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-21

On-Brand Devices [Am I Pregnant?]

• 00722355002859: Home pregnancy test for early results
• 00722355002842: Home pregnancy test for early results