AccessGUDID - DEVICE: BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack (00382904417499)

GUDID

Device Identifier (DI) Information

Brand Name: BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack
Version or Model: 441749
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 441749
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904417499
Issuing Agency: GS1
Commercial Distribution End Date: March 21, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Kit HSV 1/Hsv2 Qx 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?
49539	Herpes simplex virus 1 & 2 (HSV1 & 2) 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 herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OQO	Herpes simplex virus nucleic acid amplification assay

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103798	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: 5164c1b6-fc36-4735-99fe-873f6409e44d
Public Version Date: June 13, 2024
Public Version Number: 4
DI Record Publish Date: July 07, 2016