AccessGUDID - DEVICE: AmpliVue (30014613312093)

GUDID

Device Identifier (DI) Information

Brand Name: AmpliVue
Version or Model: Bordetella Assay
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M209
Company Name: QUIDEL CORPORATION

Primary DI Number: 30014613312093
Issuing Agency: GS1
Commercial Distribution End Date: July 20, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 079509836 *Terms of Use

Device Description: AmpliVue Bordetella Assay

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?
50505	Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Bordetella bacteria, which may include B. pertussis, B. parapertussis and/or B. bronchiseptica in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZZ	Bordetella pertussis dna assay system

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 06bc7dfa-992a-420d-b525-03e7ffe36811
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: September 15, 2016