DAVID Ovulation Test Strip RH-LH25-S

GUDID 06938444982481

DAVID Ovulation Test Strip is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 50pcs of strip in each box.

Runbio Biotech Co., Ltd.

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Primary Device ID06938444982481
NIH Device Record Key9568844b-c808-4dc6-a8b4-744c4a55394b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAVID Ovulation Test Strip
Version Model Number82481
Catalog NumberRH-LH25-S
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
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
GS106938444982481 [Primary]

FDA Product Code

NGETest, Luteinizing Hormone (Lh), Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-09
Device Publish Date2021-06-01

Devices Manufactured by Runbio Biotech Co., Ltd.

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06938444982481 - DAVID Ovulation Test Strip2021-06-09DAVID Ovulation Test Strip is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 50pcs of strip in each box.
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