FDA.reportPublic FDA data

Proov

Primary DI
00850035206164
Brand
Proov
Company
Mfb Fertility, Inc.
Model
Fertility 4-in-1 Test
Device description
A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains 3 FSH urine tests to check ovarian reserve, 10 LH tests to predict ovulation during the fertile window, 5 PdG tests to confirm ovulation during the implantation window, 2 hCG urine tests to aid in early detection of pregnancy.
Published
2023-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JHIVisual, Pregnancy Hcg, Prescription Use
LCXKit, Test, Pregnancy, Hcg, Over The Counter
NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
NGETest, Luteinizing Hormone (Lh), Over The Counter
QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2
NGATest, Follicle Stimulating Hormone (Fsh), Over The CounterClinical Chemistry1
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1
QKEImmunoassay, Pregnanediol Glucuronide, Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035206164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035206164008500352061648500352061640850035206164

GMDN Terms#

Term, Definition table
TermDefinition
Natural conception assistance kitA collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080270263
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850035206393ProovMFB-MH-102025-08-15
00850035206003ProovCheck2023-03-24
00850035206157ProovFertility 3-in-1 Test2023-05-17
00850035206065ProovComplete2023-04-20
00850035206058ProovReserve2023-04-17
00850035206102ProovPredict2023-04-17
00850035206126ProovPregnancy Pack2023-03-28
00860002790817ProovConfirm2023-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923304600193U Pregnancy TestWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-28
86950996041122Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-26
86950996013099Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-25
86950996019039Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-25
06950996006323Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06950996030694Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06950996067577Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06974464591678One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-22
06974464591685One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-22
06923304600124FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600131FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600155FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600162FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600186FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304611175FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611182FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611199FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611236FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611274FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611281FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
00036800028326TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028333TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028340TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028357TopCare HealthTopco Associates, LLCLCX2026-07-13
06972412611690LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06972412611706LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06972412611713LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
00850081966005PregmateGuangzhou Decheng Biotechnology Co., LTDNGA2026-07-08
00810174470369HORMONElife™WONDFO USA CO., LTD.NGA2026-06-26
00810174470543HORMONElife™WONDFO USA CO., LTD.LCX2026-06-26