AccessGUDID - DEVICE: First To Know Syphilis Test (00858022006018)

GUDID

Device Identifier (DI) Information

Brand Name: First To Know Syphilis Test
Version or Model: 8057-25-CP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8057-25-CP
Company Name: NOWDIAGNOSTICS, INC.

Primary DI Number: 00858022006018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 079541513 *Terms of Use

Device Description: 25 count convenience pack

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?
66561	Treponema pallidum total antibody IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to Treponema pallidum in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment to detect infection with Treponema pallidum, the bacteria associated with syphilis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SBZ	Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230090	000

Device Exempt from Premarket Submission: No 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
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c79c0685-9a4f-4ec3-a481-d8d97627b479
Public Version Date: December 17, 2024
Public Version Number: 1
DI Record Publish Date: December 09, 2024