AccessGUDID - DEVICE: N/A (00819398028714)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z51
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Z51
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398028714
Issuing Agency: GS1
Commercial Distribution End Date: December 19, 2023
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Beta Lactamase Test, acidometric method, 20 tests per package An rapid acidometric method for performing a beta-lactamase test on Haemophilus spp., S. aureus, and N. gonorrhoeae. Easy to read, clear cut color change, just add bacteria and water to tube. Not for use with anaerobes.

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):	No
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?
64046	Beta-lactamase activity IVD, kit, mass spectrometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the hydrolytic activity of a beta-lactamase enzyme (e.g., carbapenemase) in a clinical specimen, using a mass spectrometry method. This test is used to detect bacteria that are resistant to beta-lactam antibiotics such as penicillin, cephalosporin, or carbapenem (e.g., Enterobacterales, Pseudomonas spp., Acinetobacter spp.).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7bb1e62b-87b6-48ba-8497-cfacc5c14185
Public Version Date: December 20, 2023
Public Version Number: 2
DI Record Publish Date: August 07, 2020