Topcare Digital Pregnancy Test

GUDID 00036800163218

CB8 Digital Pregnancy Stick Topcare DPS Digital Early US

TOPCO ASSOCIATES, LLC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID00036800163218
NIH Device Record Key1ab521f3-69c1-4a0b-a14f-178dd6e4a9c8
Commercial Distribution Discontinuation2019-12-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTopcare Digital Pregnancy Test
Version Model NumberCB8
Company DUNS072943876
Company NameTOPCO ASSOCIATES, LLC
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com
Phone888-423-0139
Emailtopcare@topco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100036800163218 [Primary]
GS100633472000041 [Unit of Use]
GS110036800163215 [Package]
Package: Shipping Case [24 Units]
Discontinued: 2019-12-02
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-07-06
Device Publish Date2016-06-30

Devices Manufactured by TOPCO ASSOCIATES, LLC

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10036800216584 - TopCare health2024-09-18 Sterile, Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
10036800216591 - TopCare health2024-09-18 Sterile, Antibacterial, Bandage Roll, 1 roll, 4 1/2 IN x 4.1 YDS. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
10036800216607 - TopCare health2024-09-18 Sterile, Antibacterial Gauze Pads, all one size, 2 IN 2 IN, 2 dressings per wrapper. Contains: Polyhexamethylene Biguadine (PHMB
10036800232690 - TOPCARE2024-09-18 60 SECOND DIGITAL THERMOMETER RIGID TIP
10036800232706 - TOPCARE2024-09-18 60 SEC FLEX TIP DIGITAL THERMOMETER
10036800232713 - TOPCARE2024-09-18 TOPCO 10 SECOND FLEX TIP DIGITAL THERMOMETER
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