DEVICE: N/A (00816576028061)

Device Identifier (DI) Information

N/A
J71
In Commercial Distribution
J71
HARDY DIAGNOSTICS
00816576028061
GS1

10
039981550 *Terms of Use
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.
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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.
Active false
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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
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f3bb4371-979b-4e4f-9082-ace6c6db3cc6
June 01, 2020
1
May 24, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00816576027989 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-266-2222
techservice@hardydiagnostics.com
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