N/A Y310

GUDID 00819398025553

Phenol Red Broth with Maltose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the differentiation of microorganisms by carbohydrate fermentation. Contains a durham tube for gas detection.

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
Primary Device ID00819398025553
NIH Device Record Key8fc1a36f-fbc0-487b-823e-c27a4be2982f
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberY310
Catalog NumberY310
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
Device Count20
DM Exemptfalse
Pre-market Exempttrue
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
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@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

Device Identifiers

Device Issuing AgencyDevice ID
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025553 [Unit of Use]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]
GS100819398025560 [Primary]

FDA Product Code

JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test
JSFCulture Media, Single Biochemical Test

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

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