AccessGUDID - DEVICE: NeuMoDxTM GBS Test Strip (10814278020045)

GUDID

Device Identifier (DI) Information

Brand Name: NeuMoDxTM GBS Test Strip
Version or Model: 200400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200400
Company Name: Neumodx Molecular, Inc.

Primary DI Number: 10814278020045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 078667309 *Terms of Use

Device Description: NeuMoDx GBS Test Strip

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?
51756	Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from Group B beta-haemolytic Streptococcus bacteria in a clinical specimen.	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 [?]
K173725	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 Humidity: between 20 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 18 and 28 Degrees Celsius
Handling Environment Humidity: between 20 and 60 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bb4a4def-6a0f-4d50-a012-e302e50bc060
Public Version Date: April 11, 2019
Public Version Number: 1
DI Record Publish Date: April 03, 2019

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: 00814278020048 CLOSE

Direct Marking (DM)

[?]

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

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(734)372-2617
Email: ewinnega@neumodx.com

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