DEVICE: NA (00816576020102)
Device Identifier (DI) Information
NA
G14
In Commercial Distribution
G14
HARDY DIAGNOSTICS
G14
In Commercial Distribution
G14
HARDY DIAGNOSTICS
BHI AGAR with VANCOMYCIN
(Brain Heart Infusion Agar with Vancomycin 6mcg/ml). For detecting vancomycin resistant Enterococcus spp. (VRE).
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58699 | VRE/HLARE agar culture medium IVD |
A selective and/or differential agar culture medium containing specified concentrations of antimicrobials intended to be used to screen for the presence of Vancomycin-resistant Enterococci (VRE) and/or High Level Aminoglycoside Resistant Enterococci (HLARE) in a clinical specimen.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
60fe9299-7267-403e-a9fb-3559cf0a847a
March 29, 2018
2
September 01, 2016
March 29, 2018
2
September 01, 2016
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:
00816576021215
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-266-2222
techservice@hardydiagnostics.com
techservice@hardydiagnostics.com