Topcare One Step Pregnancy Test

GUDID 00036800060937

FPPL Topcare DPS +/-

TOPCO ASSOCIATES, LLC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00036800060937
• NIH Device Record Key: e0c22602-75d5-4bdb-8543-4d29ec8079a6
• Commercial Distribution Discontinuation: 2019-12-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Topcare One Step Pregnancy Test
• Version Model Number: FPPL
• Company DUNS: 072943876
• Company Name: TOPCO ASSOCIATES, LLC
• Device Count: 2
• 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: true

Customer Support Contacts

• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.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
• 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	00036800060937 [Primary]
GS1	00036800377646 [Package]; Package: Shipping Case [24 Units]; Discontinued: 2019-12-02; Not in Commercial Distribution
GS1	00633472000133 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042280

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: 6
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-06-30

On-Brand Devices [Topcare One Step Pregnancy Test]

• 00036800339774: FPPL Topcare TPS +/-
• 00036800115668: FPPL Topcare SPS +/-
• 00036800060937: FPPL Topcare DPS +/-