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Easy@Home Ovulation Test Strip (25 tests kit)

Primary DI
00850253007260
Brand
Easy@Home Ovulation Test Strip (25 tests kit)
Company
EASY HEALTHCARE CORPORATION
Model
EZW2-S-25
Catalog number
EZW2-S
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CEPRadioimmunoassay, Luteinizing Hormone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850253007267PackageGS1120In Commercial Distribution
00850253007260PrimaryGS10
30850253007261Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085025300726710850253007267
00850253007260008502530072608502530072600850253007260
3085025300726130850253007261

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
080278407
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810038638154Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
10810038638857Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
00810038638874Easy@Home Smart Basal ThermometerEBT-300 PINK2025-07-31
00810038638881Easy@Home Smart Basal ThermometerEBT-300 PURPLE2025-07-31
00810038638898Easy@Home Digital Basal ThermometerEBT-018 PINK2025-07-31
00810038638904Easy@Home Digital Basal ThermometerEBT-018 PURPLE2025-07-31
00810038638928Premom Smart Basal ThermometerEBT-3802025-07-31
00810038638935Easy@Home Digital ThermometerEMT-0262025-07-31
00810038638942Easy@Home Rectal Digital ThermometerEMT-0272025-07-31
00810038638959Easy@Home Digital ThermometerEMT-A122025-07-31
00810038638973Premom Smart Basal ThermometerEBT-3802025-07-31
10810038637157easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
10810038638048easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
10810038638864Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17
00810038638911Easy@Home Dual Digital ThermometerEBT-0132025-07-17
00810038633992Easy@Home Dual Digital ThermometerEBT-0132023-01-30
10810038638093Easy@Home Marijuana Test Strip(THC 20)ESTH-215ESTH-215-52025-07-10
00810038637365easy@Home TENS AND MUSCLE STIMULATOREHE0802025-04-17
10810038636846Easy@Home Pregnancy Test (5 tests) EZW1-MDEZW1-MD-52024-11-08
10810038636266Easy@Home Blood Pressure Monitor EBP-095 BlackEBP-0952024-11-04

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