N/A

Primary DI
00819398026482
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Z40
Catalog number
Z40
Device description
Strep B Carrot Broth™ One-Step, 13x100mm Tube, 4ml Strep 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
Rx
false
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
20
DM exempt
false
Premarket exempt
false
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

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
00819398026499N/AHARDY DIAGNOSTICSPQZ2020-05-11