AccessGUDID - DEVICE: BD ProbeTec™ ET CT/GC Reagent Pack (00382904407056)

GUDID

Device Identifier (DI) Information

Brand Name: BD ProbeTec™ ET CT/GC Reagent Pack
Version or Model: 440705
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 440705
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904407056
Issuing Agency: GS1
Commercial Distribution End Date: June 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Kit CT/GC Amplified Dna 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:	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?
47320	Chlamydia trachomatis 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 Chlamydia trachomatis bacteria in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSL	DNA-REAGENTS, NEISSERIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984631	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: 7b228d11-0b86-4952-b225-cdc04011512c
Public Version Date: November 18, 2022
Public Version Number: 4
DI Record Publish Date: July 07, 2016