Modern Fertility Pregnancy Test

GUDID 00860000599634

Modern Fertility Pregnancy Test 4ct

MODERN HEALTH

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00860000599634
NIH Device Record Keyd8da7b01-32b7-40b5-9e56-2be0c92272e4
Commercial Distribution Discontinuation2021-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameModern Fertility Pregnancy Test
Version Model NumberA
Company DUNS115270384
Company NameMODERN HEALTH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000599634 [Primary]

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 Number2
Public Version Date2022-03-10
Device Publish Date2020-06-17

On-Brand Devices [Modern Fertility Pregnancy Test]

00860000599610Modern Fertility Pregnancy Test 2ct
00850029375043Modern Fertility Pregnancy Test 4ct - Box with Window
00850029375029Modern Fertility Pregnancy Test 4ct with Belly Band Box
00860000599634Modern Fertility Pregnancy Test 4ct

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