AccessGUDID - DEVICE: MobiLab Standard Sexual Health Self Rapid Test (00860008737304)

GUDID

Device Identifier (DI) Information

Brand Name: MobiLab Standard Sexual Health Self Rapid Test
Version or Model: MSSH
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MobiLab Medical Innovatives Inc.

Primary DI Number: 00860008737304
Issuing Agency: GS1
Commercial Distribution End Date: February 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 119151799 *Terms of Use

Device Description: The MobiLab Standard Sexual Health Self Screening Kit (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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64387	Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use	A collection of devices intended to be used by a layperson in the home to collect a clinical specimen for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXA	Kit, Screening, Urine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44414694-010f-4c8b-a119-04d0eed84aa6
Public Version Date: April 04, 2025
Public Version Number: 5
DI Record Publish Date: February 05, 2024