AccessGUDID - DEVICE: Control Set for the BD ProbeTec™ Trichomonas vaginalis (00382904419189)

GUDID

Device Identifier (DI) Information

Brand Name: Control Set for the BD ProbeTec™ Trichomonas vaginalis
Version or Model: 441918
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 441918
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904419189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Control Set for the BD ProbeTec™ Trichomonas vaginalis (TV) Qx Amplified DNA Assay, 48

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:	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?
52477	Trichomonas vaginalis nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from the parasitic protozoan Trichomonas vaginalis in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUY	Trichomonas vaginalis nucleic acid amplification test system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130268	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
Storage Environment Temperature: between 2 and 33 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96db0b5a-7f37-47c0-b149-8ecac6c3f797
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 07, 2016