Publix One Step Pregnancy Test

GUDID 00041415024762

FPPL Publix DPS +/-

PUBLIX SUPER MARKETS, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID00041415024762
NIH Device Record Keyc063933d-f3e6-49da-8ce0-123722dcdee7
Commercial Distribution Discontinuation2021-02-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePublix One Step Pregnancy Test
Version Model NumberFPPL
Company DUNS006922009
Company NamePUBLIX SUPER MARKETS, INC.
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

Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
Emailxx@xx.xx
Phone888-267-3037
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100041415024762 [Primary]
GS100633472000133 [Unit of Use]
GS110041415024769 [Package]
Package: Shipping Case [12 Units]
Discontinued: 2021-02-11
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 Number4
Public Version Date2021-02-12
Device Publish Date2016-08-10

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