DAVID Ovulation Test RH-LH25-B

GUDID 06938444982405

DAVID Ovulation Test 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 5pcs of midstream in each box.

Runbio Biotech Co., Ltd.

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID06938444982405
NIH Device Record Keya0e808c7-2334-46ba-a6a5-922b8345beae
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAVID Ovulation Test
Version Model Number82405
Catalog NumberRH-LH25-B
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

Device Identifiers

Device Issuing AgencyDevice ID
GS106938444982405 [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 Date2020-12-10
Device Publish Date2020-12-02

On-Brand Devices [DAVID Ovulation Test ]

06938444982405DAVID Ovulation Test is a self-testing rapid chromatographic immunoassay for the qualitative det
06938444982399DAVID Ovulation Test is a self-testing rapid chromatographic immunoassay for the qualitative det

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.