N/A

Primary DI
00819398026536
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Z53
Catalog number
Z53
Device description
RSU Broth (rapid sucrose urea), for Corynebacterium jeikeium, 0.5ml, 10 tubes per package RSU Broth, 0.5ml (Rapid Sucrose Urea) minitube (15x45mm) culture test for the presumptive identification of Corynebacterium jeikeium. Same day results, performs a sucrose fermentation and urease test, both of which are negative for C. jeikeium.
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSECulture Media, Multiple Biochemical Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSECulture Media, Multiple Biochemical TestMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398026543PrimaryGS10
00819398026536Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398026543008193980265438193980265430819398026543
00819398026536008193980265368193980265360819398026536

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective broth culture medium IVDA broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00819398024594N/AY100Y1002020-06-08
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00819398022774N/AHARDY DIAGNOSTICSJSE2020-06-04
00819398022767N/AHARDY DIAGNOSTICSJSE2020-06-04
00819398020855N/AHARDY DIAGNOSTICSJSE2020-05-24
00819398020848N/AHARDY DIAGNOSTICSJSE2020-05-24
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