FDA.report

Easy@Home Ovulation Test Kit (50 LH strips + 50 HCG strips )

Primary DI
10855944007014
Brand
Easy@Home Ovulation Test Kit (50 LH strips + 50 HCG strips )
Company
EASY HEALTHCARE CORPORATION
Model
EZ-WS5050
Catalog number
EZW2-S, EZW1-S
Device description
50 LH strips + 50 HCG strips
Published
2017-05-05
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

Related Records

Product Codes

CodeName
CEPRadioimmunoassay, Luteinizing Hormone

Product Code Classifications

CodeDeviceSpecialtyClass
CEPRadioimmunoassay, Luteinizing HormoneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10855944007014PackageGS140In Commercial Distribution
00855944007017PrimaryGS10
30855944007018Unit of UseGS10

GMDN Terms

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

Regulatory Flags

DUNS number
080278407
Device count
100
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
false
Sterilization required before use
false

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