AccessGUDID - DEVICE: BD MAX™ CT/GC/TV (00382904429706)

GUDID

Device Identifier (DI) Information

Brand Name: BD MAX™ CT/GC/TV
Version or Model: 442970
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 442970
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904429706
Issuing Agency: GS1
Commercial Distribution End Date: October 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD MAX™ CT/GC/TV Contains: 24 each, Master Mix, Extraction Tubes, Septum Caps, Strips-Containing, Wash Buffer, Elution Buffer, Neutralization Buffer

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?
50409	Multiple-type sexually transmitted pathogen 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 multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUY	Trichomonas vaginalis nucleic acid amplification test system
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
LSL	DNA-REAGENTS, NEISSERIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151589	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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 92fbd0a6-e5d6-43d1-8ba8-919a5078c971
Public Version Date: October 17, 2024
Public Version Number: 5
DI Record Publish Date: May 25, 2018