DG Health One Step Pregnancy Test

GUDID 00430000702077

FHC-102H Dollar General Preg One Step Cassette

DOLGENCORP, LLC

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00430000702077
NIH Device Record Keyf1234d07-e812-41f1-a6da-0aa568982c77
Commercial Distribution StatusIn Commercial Distribution
Brand NameDG Health One Step Pregnancy Test
Version Model NumberFHC-102H
Company DUNS068331990
Company NameDOLGENCORP, 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

Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx
Phone888-309-9030
Emailxx@xx.xx

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
GS100430000702077 [Primary]
GS110430000702074 [Package]
Package: Shipping Case [96 Units]
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 Number3
Public Version Date2018-07-06
Device Publish Date2016-06-30

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10751774250784 - DG health2023-11-06 DOLLAR GENERAL 5D ONE STEP PREG CASSETTE
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