SMILEREADER Ovulation Test Kit

GUDID 06938444982351

The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips .

Equinox Biotech Co., Ltd.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID06938444982351
NIH Device Record Keya2e2e908-2cee-4465-9c19-a0808c4fec1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMILEREADER Ovulation Test Kit
Version Model Number82351
Company DUNS545868502
Company NameEquinox Biotech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS106938444982351 [Primary]

FDA Product Code

OIEUrine Collection Kit (Excludes Hiv Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-11-23
Device Publish Date2020-06-10

Devices Manufactured by Equinox Biotech Co., Ltd.

06938444982719 - ZiQ2025-03-03 ZiQ Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG
06938444981316 - INVBIO2022-11-23 HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropi
06938444981323 - INVBIO2022-11-23 The convenience kit consisiting of 50 ovulation test strips 3mm and 20 pregnancy test strips 3mm.
06938444982238 - AFAC One Step HCG and Ovulation Urine test Kit2022-11-23 The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips .
06938444982351 - SMILEREADER Ovulation Test Kit 2022-11-23The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips .
06938444982351 - SMILEREADER Ovulation Test Kit 2022-11-23 The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips .

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