294487

GUDID 00816576022335

V.cholerae As O139 Bengal, 2ml

HARDY DIAGNOSTICS

Multiple Vibrio species culture isolate identification IVD, reagent
Primary Device ID00816576022335
NIH Device Record Key57cc4244-9c8b-44d5-827f-e96fc40ccbba
Commercial Distribution Discontinuation2018-09-25
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number294487
Catalog Number294487
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816576022335 [Primary]

FDA Product Code

GSQAntiserum, Vibrio Cholerae, All Varieties

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-31
Device Publish Date2016-09-17

Devices Manufactured by HARDY DIAGNOSTICS

00816576025800 - TransPRO2024-10-16 TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-ti
00816576026951 - N/A2024-07-16 G Vag Starch Agar, 15x100mm Monoplate. For the selective isolation and differentiation of Gardnerella vaginalis from other micro
00816576026586 - N/A2024-04-05 Hektoen Enteric (HE) Agar / SS Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective an
00816576026876 - N/A2024-03-18 C. auris Enrichment Broth, Fill 2mL (Sabouraud Salt Dulcitol Broth with Chloramphenicol & Gentamicin) For the selective enrichme
00819398021593 - N/A2024-01-23 BHI Broth, 4mL, 100 tubes/pack (Brain Heart Infusion Broth) For the cultivation of fastidious and nonfastidious microorganisms.
00819398020602 - N/A2024-01-09 Modified Diamonds Medium, 16x100mm Tube, 6ml. Hardy Diagnostics Modified Diamonds Medium is recommended as an enriched and sele
00816576026838 - HardyCHROM™2023-12-18 HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogen
00816576024391 - AnaeroGRO2023-12-06 Bacteroides Bile Esculin Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selectiv

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.