FDA.reportPublic FDA data

OvuQuick Ovulation Predictor Test

Primary DI
10805360016039
Brand
OvuQuick Ovulation Predictor Test
Company
VITROLIFE INC.
Model
15101
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CEPRadioimmunoassay, Luteinizing Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEPRadioimmunoassay, Luteinizing HormoneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K871726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871726000OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)Monoclonal Antibodies, Inc.1987-07-27CEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10805360016039PrimaryGS10
00805360016032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080536001603910805360016039
00805360016032008053600160328053600160320805360016032

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.

Regulatory Flags#

DUNS number
051915038
Device count
9
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00805360016865Enhance Sperm Wash w/ Gentamicin152632018-04-20
00805360018494Enhance Water for Tissue Culture155222018-04-23
00805360014106Handling Pipette155302021-09-03
00805360014113Handling Pipette155312021-09-03
00805360014120Handling Pipette155322021-09-03
00805360014144Handling Pipette155332021-09-03
00805360014151Handling Pipette155342021-09-03
00805360014168Handling Pipette155352021-09-03
00805360014175Handling Pipette155362021-09-03
00805360014182Handling Pipette155372021-09-03
00805360014199Handling Pipette155382021-09-03
10805360014103Handling Pipette155302021-09-03
10805360014110Handling Pipette155312021-09-03
10805360014127Handling Pipette155322021-09-03
10805360014141Handling Pipette155332021-09-03
10805360014158Handling Pipette155342021-09-03
10805360014165Handling Pipette155352021-09-03
10805360014172Handling Pipette155362021-09-03
10805360014189Handling Pipette155372021-09-03
10805360014196Handling Pipette155382021-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970429844124FloCo-Innovation Biotech Co., LtdCEP2026-03-31
07613336218402Elecsys LHRoche Diagnostics GmbHCEP2026-02-19
00850054026712AccuDiag™ LH ELISADiagnostic Automation, Inc.CEP2026-01-30
10850049545492QMedix™Diagnostic Automation, Inc.CEP2025-12-24
00850049545495QMedix™Diagnostic Automation, Inc.CEP2025-12-24
06923304611144Sims ovulation test kitWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2025-12-03
06970429844117co-innovationCo-Innovation Biotech Co., LtdCEP2025-10-20
14562185399711CL AIA-PACK LH TEST CUPTOSOH CORPORATIONCEP2025-09-01
24562185399718CL AIA-PACK LH TEST CUPTOSOH CORPORATIONCEP2025-09-01
04048474012897LH-Serum ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2024-11-22
04048474012903LH-Urine ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2024-11-22
15099590575243Access hLHBeckman Coulter, Inc.CEP2024-04-23
06923304611120FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2024-01-11
06923304611137FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2024-01-11
00050428296646CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCEP2023-10-25
10050428296643CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCEP2023-10-25
04048474053623LHDRG Instruments Gesellschaft mit beschränkter HaftungCEP2023-09-01
04048474041033LH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEP2023-08-31
00840239053626LHDRG International IncCEP2023-08-26
00840239012890LH-Serum ELISADRG International IncCEP2023-08-22
00840239012906LH-Urine ELISADRG International IncCEP2023-08-22
06923304611113INSTANT Aid By PUR-estWeihai Kangzhou Biotechnology Engineering Co., LtdCEP2023-08-15
15099590232276Access hLH CalibratorBeckman Coulter, Inc.CEP2023-06-26
00810038634036Easy@Home Ovulation Test Kit (25 LH strips + 10 HCG strips)EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038634050Easy@Home Ovulation Test Kit (15 LH strips + 5 HCG strips ) EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038634586Easy@Home Ovulation Test Kit (20 LH strips + 5 HCG strips ) EASY HEALTHCARE CORPORATIONCEP2023-01-11
00810038633787Easy@Home Ovulation Test Kit (30 LH strips+30 Cups)EASY HEALTHCARE CORPORATIONCEP2023-01-09
00810038634029Easy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips + 50 Cups )EASY HEALTHCARE CORPORATIONCEP2023-01-09
00810038634487Easy@Home Ovulation Test Kit (25 LH strips + 10 HCG strips + 40 Cups ) EASY HEALTHCARE CORPORATIONCEP2023-01-09
B261CANLH40400DBC Luteinizing Hormone (LH) ELISADiagnostics Biochem Canada IncCEP2022-11-15