AccessGUDID - DEVICE: D3 Fastpoint (30014613330851)

GUDID

Device Identifier (DI) Information

Brand Name: D3 Fastpoint
Version or Model: 01-123104
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-123104
Company Name: DIAGNOSTIC HYBRIDS, INC.

Primary DI Number: 30014613330851
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117359612 *Terms of Use

Device Description: L-DFA Influenza A/Influenza B Reagent

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?
49117	Influenza A/B 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 influenza A virus and/or influenza B virus in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091171	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8523cff2-06e8-463d-b483-694a19b3ff41
Public Version Date: June 29, 2023
Public Version Number: 2
DI Record Publish Date: March 07, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(858)552-1100
Email: technicalsupport@quidel.com

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