N/A

Primary DI
00819398026499
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Z40
Catalog number
Z40
Device description
Strep B Carrot Broth™ One-Step, 13x100mm Tube, 4mlStrep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women.
Published
2020-05-11
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
PQZGbs Culture Media, Selective And Differential

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170586000Strep B Carrot Broth One-StepHardy Diagnostics2017-05-22PQZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398026499PrimaryGS10
00819398026482Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398026499008193980264998193980264990819398026499
00819398026482008193980264828193980264820819398026482

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

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10819398020579Carrot Broth™HARDY DIAGNOSTICSPQZ2023-02-20
00819398028523Strep B Carrot Broth™HARDY DIAGNOSTICSPQZ2020-08-07
00819398028530Strep B Carrot Broth™HARDY DIAGNOSTICSPQZ2020-08-07
00819398028509Strep B Carrot Broth™HARDY DIAGNOSTICSPQZ2020-08-07
00819398028516Strep B Carrot Broth™HARDY DIAGNOSTICSPQZ2020-08-07
03573026598075chromID® Strepto B agarBIOMERIEUX SAPQZ2020-05-19
00816576024995N/AHARDY DIAGNOSTICSPQZ2020-05-18
00819398026482N/AHARDY DIAGNOSTICSPQZ2020-05-11