Modern Fertility Pregnancy Test

GUDID 00850029375043

Modern Fertility Pregnancy Test 4ct - Box with Window

MODERN HEALTH

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 (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 (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 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 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 ID	00850029375043
NIH Device Record Key	b08857df-c76d-46f3-8077-e99a477559c4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Modern Fertility Pregnancy Test
Version Model Number	1
Company DUNS	115270384
Company Name	MODERN HEALTH
Device Count	4
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Operating and Storage Conditions

Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850029375043 [Unit of Use]
GS1	00850029375203 [Primary]
GS1	00860000599689 [Primary]
GS1	00860000599696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K150022

FDA Product Code

LCX	Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-07-19
Device Publish Date	2021-07-09

On-Brand Devices [Modern Fertility Pregnancy Test]

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