Topcare One Step Pregnancy Test

GUDID 00036800115668

FPPL Topcare SPS +/-

TOPCO ASSOCIATES, LLC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID00036800115668
NIH Device Record Keye1e6db87-bc2e-4ae9-b59a-a2bd98847fba
Commercial Distribution Discontinuation2019-12-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTopcare One Step Pregnancy Test
Version Model NumberFPPL
Company DUNS072943876
Company NameTOPCO ASSOCIATES, LLC
Device Count1
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

Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
Emailtopcare@topco.com
Phone800-899-7353
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
GS100036800115668 [Primary]
GS100036800377639 [Package]
Package: Shipping Case [24 Units]
Discontinued: 2019-12-02
Not in Commercial Distribution
GS110036800387840 [Package]
Package: Shipping Case [6 Units]
Discontinued: 2017-02-06
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

On-Brand Devices [Topcare One Step Pregnancy Test]

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