MobiLab Standard Sexual Health Self Rapid Test

GUDID 00860008737304

The MobiLab Standard Sexual Health Rapid Test (urine specimen) includes individual test cassettes for: 1. Trichomonas vaginalis (TV), 2. Candida albicans (yeast) (CA), 3. Gardnerella vaginalis (GV) 4. Mycoplasma Genitalium (MG) 5. Chlamydia trachomatis (CHT) 6. Neisseria gonorrhoeae (NGH). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.

MobiLab Medical Innovatives Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
Primary Device ID00860008737304
NIH Device Record Key44414694-010f-4c8b-a119-04d0eed84aa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobiLab Standard Sexual Health Self Rapid Test
Version Model NumberMSSH
Company DUNS119151799
Company NameMobiLab Medical Innovatives Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Customer Support Contacts

Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com
Phone877-288-4898
EmailInfo@mobilabstore.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008737304 [Primary]

FDA Product Code

JXAKit, Screening, Urine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-13
Device Publish Date2024-02-05

Devices Manufactured by MobiLab Medical Innovatives Inc.

00860008737359 - Know Rapid STD Test2024-02-14 The MobiLab Standard Sexual Health Rapid Test (urine specimen) includes individual test cassettes for: 1. Trichomonas vaginalis
00860008737304 - MobiLab Standard Sexual Health Self Rapid Test2024-02-13The MobiLab Standard Sexual Health Rapid Test (urine specimen) includes individual test cassettes for: 1. Trichomonas vaginalis (TV), 2. Candida albicans (yeast) (CA), 3. Gardnerella vaginalis (GV) 4. Mycoplasma Genitalium (MG) 5. Chlamydia trachomatis (CHT) 6. Neisseria gonorrhoeae (NGH). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.
00860008737304 - MobiLab Standard Sexual Health Self Rapid Test2024-02-13 The MobiLab Standard Sexual Health Rapid Test (urine specimen) includes individual test cassettes for: 1. Trichomonas vaginalis
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