Modern Fertility Ovulation Test

GUDID 00860000599627

Modern Fertility Ovulation Test 20ct

MODERN HEALTH

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00860000599627
NIH Device Record Key488db016-be30-4dae-9424-fe3389787c64
Commercial Distribution Discontinuation2021-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameModern Fertility Ovulation Test
Version Model NumberA
Company DUNS115270384
Company NameMODERN HEALTH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000599627 [Primary]

FDA Product Code

NGETest, Luteinizing Hormone (Lh), 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 Ovulation Test]

00850029375012Modern Fertility Ovulation Test 20ct with Belly Band Box
00850029375036Modern Fertility Ovulation Test 20ct - Box with Window
00860000599627Modern Fertility Ovulation Test 20ct

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