AccessGUDID - DEVICE: cobas PCR Media Dual Swab Sample Kit (00875197005738)

GUDID

Device Identifier (DI) Information

Brand Name: cobas PCR Media Dual Swab Sample Kit
Version or Model: 07958021190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07958021190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197005738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071674100 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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
LSL	DNA-REAGENTS, NEISSERIA
OOI	real time Nucleic acid amplification system
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
LIO	Device, specimen collection

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dad26b9d-9a88-40c2-9a93-3fd4695ff15b
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: June 27, 2017