Primary Device ID | 00036800384316 |
NIH Device Record Key | 9d8cec35-8083-481b-b3ca-32f71fa2a4d3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Topcare Early Result Pregnancy Test |
Version Model Number | PLPL |
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 |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com | |
Phone | 800-423-0139 |
topcare@topco.com |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00036800384316 [Primary] |
GS1 | 00633472000126 [Unit of Use] |
GS1 | 10036800384313 [Package] Package: Shipping Case [24 Units] In Commercial Distribution |
GS1 | 10036800387833 [Package] Package: Shipping Case [7 Units] Discontinued: 2016-03-09 Not in Commercial Distribution |
LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2023-07-06 |
Device Publish Date | 2016-06-30 |
10036800396934 - TOPCARE | 2023-11-13 TOPCARE 30 SECOND THERMOMETER |
00036800060937 - Topcare One Step Pregnancy Test | 2023-07-06 FPPL Topcare DPS +/- |
00036800115668 - Topcare One Step Pregnancy Test | 2023-07-06 FPPL Topcare SPS +/- |
00036800163218 - Topcare Digital Pregnancy Test | 2023-07-06 CB8 Digital Pregnancy Stick Topcare DPS Digital Early US |
00036800339774 - Topcare One Step Pregnancy Test | 2023-07-06 FPPL Topcare TPS +/- |
00036800384316 - Topcare Early Result Pregnancy Test | 2023-07-06Topcare DPS Early |
00036800384316 - Topcare Early Result Pregnancy Test | 2023-07-06 Topcare DPS Early |
20036800186808 - TopCare health | 2023-04-04 Sterile Rolled Gauze, 1 roll, 4 IN x 2 1/2 YDS |
30036800188205 - TopCare health | 2023-04-04 Sterile Rolled Gauze, 1 roll, 2 in x 2 1/2 YDS |