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

• 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