AccessGUDID - DEVICE: Xpert MRSA/SA SSTI (07332940000189)

GUDID

Device Identifier (DI) Information

Brand Name: Xpert MRSA/SA SSTI
Version or Model: GXMRSA/SA-SSTI-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GXMRSA/SA-SSTI-10
Company Name: CEPHEID

Primary DI Number: 07332940000189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 956711444 *Terms of Use

Device Description: Xpert MRSA/SA SSTI kit; 10 test kit

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:	Yes
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?
60864	MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080837	000
K243625	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 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6521454e-6a4f-451a-a36e-5eef9d5f3424
Public Version Date: February 20, 2025
Public Version Number: 5
DI Record Publish Date: January 29, 2018