Dr. Talbot's

GUDID 00370797011009

TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00370797011009
NIH Device Record Key1d177991-ce25-487e-86e0-b54e4be9b63e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDr. Talbot's
Version Model Number1100
Company DUNS078855555
Company NameTALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100370797011009 [Primary]
GS120370797011003 [Package]
Package: [6 Units]
In Commercial Distribution
GS130370797011000 [Package]
Contains: 20370797011003
Package: [4 Units]
In Commercial Distribution

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-02
Device Publish Date2020-10-23