N/A

Primary DI
00819398023757
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
R93
Catalog number
R93
Device description
ONPG-PDA, for rapid lactose fermentation and phenylalanine deaminase detection, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20To aid in the rapid identification of Salmonella and Shigella spp. in clinical specimens. Detects beta-galactosidase and phenylalanine deaminase activity.
Published
2020-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00819398023757PrimaryGS10
00819398023740Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398023757008193980237578193980237570819398023757
00819398023740008193980237408193980237400819398023740

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 Temperature0 Degrees Celsius-10 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00819398024594N/AY100Y1002020-06-08
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00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
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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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