FDA.report

N/A

Primary DI
00819398022682
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Q10
Catalog number
Q10
Device description
Motility Test Medium, 8ml, 16x100mm tube, order by the package of 20 Motility Test Medium with and without Triphenyltetrazolium Chloride (TTC) is recommended for the detection of motility in gram-negative enteric bacilli. TTC is added to enhance visualization of bacterial growth
Published
2020-06-04
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

Related Records

Contact Domains

Product Codes

CodeName
JSHCulture Media, Non-Selective And Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819398022699PrimaryGS10
00819398022682Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398022699008193980226998193980226990819398022699
00819398022682008193980226828193980226820819398022682

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags

DUNS number
039981550
Device count
20
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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