DAVID OVULATION TEST KIT

GUDID 06938444980128

The convenience kit consisting of 50 Ovulation Test device and 25 Pregnancy Test devices.

Runbio Biotech Co., Ltd.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID06938444980128
NIH Device Record Key7c8e3c6c-3a3d-490c-b9ff-87a4bbb34a7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAVID OVULATION TEST KIT
Version Model Number80128
Company DUNS545868502
Company NameRunbio 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
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS106938444980128 [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 Number3
Public Version Date2019-02-21
Device Publish Date2016-09-07

Devices Manufactured by Runbio Biotech Co., Ltd.

06938444982641 - DAVID2022-07-25 DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregnancy test strips and 2 pregnancy crysta
06938444982603 - DAVID2022-07-11 DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and 30 pregnancy test strips .
06938444982610 - DAVID2022-07-11 DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in
00850014758431 - NATALIST PREGNANCY TEST STRIP 15 COUNT2022-02-04 NATALIST PREGNANCY TEST STRIP 15 COUNT is intended for the qualitative determination of human chorionic gonadotropin (hCG) in th
06938444982498 - OT80-Beurer Ovulation Predictor and Fertility Tracking Kit2021-07-08 The product consist of 15 ovulation test strips, 15 FSH test strips and 2 pregnancy test strips.
06938444982481 - DAVID Ovulation Test Strip2021-06-09 DAVID Ovulation Test Strip is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizin
06938444982412 - DAVID2021-05-04 The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strips .
00850014758042 - NATALIST OVULATION TEST MIDSTREAM 10 COUNT2021-01-11 NATALIST OVULATION TEST MIDSTREAM 10 COUNT is a self-testing rapid chromatographic immunoassay for the qualitative detection of

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