FDA.reportPublic FDA data

N/A

Primary DI
00816576024995
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
G123
Catalog number
G123
Device description
Granada Medium, 15x100mm Plate, 19ml. Granada Medium is a selective and differential agar which is intended for the qualitative detection of Group B Streptococcus (GBS) from LIM Broth enrichment cultures of vaginal/rectal swabs from antepartum women following 18-24 hours of incubation.
Published
2020-05-18
Public version status
Update
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
JSICulture Media, Selective And Differential
PQZGbs Culture Media, Selective And Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1
PQZGbs Culture Media, Selective And DifferentialMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173903000Granada MediumHardy Diagnostics2018-03-22PQZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576024995PrimaryGS10
00816576024988Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576024995008165760249958165760249950816576024995
00816576024988008165760249888165760249880816576024988

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar 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 on the same medium by appearance (e.g., colour, shape, growth pattern). 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
Special Storage Condition, Specify00Store and incubate media in the dark
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
10
Lot or batch
true
Expiration date on label
true

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00819398023610N/AR76BXR76BX2020-06-05
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