Carrot Broth™ Z140T

GUDID 10819398020579

Strep B Carrot Broth™ Tiles, for the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tiles must be added to broth (not included) upon inoculation.

HARDY DIAGNOSTICS

Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD
Primary Device ID10819398020579
NIH Device Record Key6b74fced-062e-45ea-8501-bf25a4b783ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarrot Broth™
Version Model NumberZ140T
Catalog NumberZ140T
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com
Phone800-266-2222
EmailTechnicalServices@HardyDiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100819398020572 [Unit of Use]
GS110819398020579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQZGbs Culture Media, Selective And Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-28
Device Publish Date2023-02-20

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