Ovulation Test

Primary DI
00860008449016
Brand
Ovulation Test
Company
The Bird And Be Co Inc
Model
LHUS
Device description
Rapid chromatographic immunoassays for the qualitative detection of LH in urine, as an aid in detection of ovulation. This test is intended for over-the-counter use.
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008449016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008449016008600084490168600084490160860008449016

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment as an ovulation signal to optimise the chances of natural conception.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
208597925
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008449009Early Pregnancy TestHCGUS2022-06-08