DAVID Pregnancy Test RH-HCG10-B

GUDID 06938444982382

DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 2 midstreams in one box.

Runbio Biotech Co., Ltd.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID06938444982382
NIH Device Record Keydfcb0f0f-2690-40c9-b79a-cc6c7de090f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDAVID Pregnancy Test
Version Model Number82382
Catalog NumberRH-HCG10-B
Company DUNS545868502
Company NameRunbio Biotech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS106938444982382 [Primary]

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, 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 Pregnancy Test]

06938444982382DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotrop
06938444982375DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotrop
06938444982368DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotrop

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