AccessGUDID - DEVICE: Xpert GBS (07332940000127)

GUDID

Device Identifier (DI) Information

Brand Name: Xpert GBS
Version or Model: GXGBS-100N-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GXGBS-100N-10
Company Name: CEPHEID

Primary DI Number: 07332940000127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 956711444 *Terms of Use

Device Description: Xpert GBS 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?
51753	Beta-haemolytic Group B Streptococcus 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 Group B beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060540	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: 495a09ce-7cd6-4433-887f-9ce579c2cae3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 29, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1 888 838 3222
Email: techsupport@cepheid.com

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