292483

GUDID 00816576025091

Salmonella Poly A-G Antisera, 2ml

HARDY DIAGNOSTICS

Multiple Salmonella species culture isolate antigen IVD, reagent Multiple Salmonella species culture isolate antigen IVD, reagent Multiple Salmonella species culture isolate antigen IVD, reagent
Primary Device ID00816576025091
NIH Device Record Key73f35b14-9e1d-4c8a-bf00-084fe2d2c077
Commercial Distribution Discontinuation2018-08-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number292483
Catalog Number292483
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
GS100816576025091 [Primary]

FDA Product Code

GRMAntisera, All Groups, Salmonella Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-31
Device Publish Date2017-08-16

Devices Manufactured by HARDY DIAGNOSTICS

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
00819398020725 - HardyDisk™2023-11-29 Sulbactam / Durlobactam 10 /10 µg (SUD20), 5 x 50 disks, used for semi-quantitative in vitro susceptibility testing by the agar
00819398023627 - N/A2023-11-28 PPLO Broth, for Mycoplasma pneumoniae, 5ml, 13x100mm tube, order by the package of 20 For the cultivation and maintenance of myc

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