FDA.report

Premom Ovulation Test Kit (60 LH + 20 HCG)

Primary DI
00855944007338
Brand
Premom Ovulation Test Kit (60 LH + 20 HCG)
Company
EASY HEALTHCARE CORPORATION
Model
PM2-S,PM1-S
Catalog number
PMS-6020
Device description
Premom 30 LH Ovulation Strips and 10 HCG Pregnancy Strips Kit (60 LH + 20 HCG)
Published
2018-07-01
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
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00855944007338PrimaryGS10
30855944007339Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00855944007338008559440073388559440073380855944007338
3085594400733930855944007339

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
80
DM exempt
false
Premarket exempt
false
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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