Kroger One Step Pregnancy Test

GUDID 00011110382443

FPPL Kroger DPS +/-

KROGER CO., THE

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID00011110382443
NIH Device Record Key08cee70b-4576-400d-973b-1ea8b66a9173
Commercial Distribution StatusIn Commercial Distribution
Brand NameKroger One Step Pregnancy Test
Version Model NumberFPPL
Company DUNS006999528
Company NameKROGER CO., THE
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

Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
Emailxx@xx.xx
Phone800-632-6900
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100011110382443 [Primary]
GS100633472000133 [Unit of Use]
GS110041260365505 [Package]
Package: Shipping case [24 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 Number4
Public Version Date2023-07-06
Device Publish Date2016-06-30

On-Brand Devices [Kroger One Step Pregnancy Test]

00011110382443FPPL Kroger DPS +/-
00011110375759FPPL Kroger SPS +/-

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