AccessGUDID - DEVICE: D3 Fastpoint (30014613330752)

GUDID

Device Identifier (DI) Information

Brand Name: D3 Fastpoint
Version or Model: Respiratory Virus ID Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-120000
Company Name: DIAGNOSTIC HYBRIDS, INC.

Primary DI Number: 30014613330752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117359612 *Terms of Use

Device Description: D3 FASTPOINT RESP VIRUS ID KIT

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
48243	Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen, using a fluorescent immunoassay method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GQS	ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4
OMG	Antisera, fluorescent, human metapneumovirus
GNS	ANTISERA, HAI, INFLUENZA VIRUS A, B, C
LKT	RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA
GNY	ANTISERA, FLUORESCENT, ADENOVIRUS 1-33

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dda5622c-fbb0-4bc6-aa87-6d4706b303e1
Public Version Date: May 23, 2025
Public Version Number: 6
DI Record Publish Date: September 15, 2016