DEVICE: N/A (00816576028061)
Device Identifier (DI) Information
N/A
J71
In Commercial Distribution
J71
HARDY DIAGNOSTICS
J71
In Commercial Distribution
J71
HARDY DIAGNOSTICS
Urine Quad Plate (EMB/Modified XLD/Simmons Citrate/Blood Agar, 5%), 15x100mm Plate, 20ml.
Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. Hardy Diagnostics Simmons Citrate Agar is recommended for use in the differentiation of gram-negative enteric bacilli based on citrate utilization. Hardy Diagnostics XLD Agar with Novobiocin is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens from foods or other samples. Modified XLD Agar is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens from specimens.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
62106 | Multiple formulation agar culture medium IVD |
A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KZI | Culture Media, Enriched |
JSH | Culture Media, Non-Selective And Differential |
JSI | Culture Media, Selective And Differential |
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 |
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No Device Sizes |
Device Record Status
f3bb4371-979b-4e4f-9082-ace6c6db3cc6
June 01, 2020
1
May 24, 2020
June 01, 2020
1
May 24, 2020
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:
00816576027989
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-266-2222
techservice@hardydiagnostics.com
techservice@hardydiagnostics.com