FDA Registration
Active
🇺🇸 United States
Hardy Diagnostics
Reg #: 3009547954
·
FEI: 3009547954
·
Expires 2026
Products
21
Proprietary Names
369
Establishment Types
6
Classifications
21
Registration Details
- Registration Name
- Hardy Diagnostics
- Registration Number
- 3009547954
- FEI Number
- 3009547954
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 429 S Pioneer Blvd
- City
- Springboro
- State
- OH
- ZIP
- 45066
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233534
Owner / Operator
- Firm Name
- HARDY DIAGNOSTICS
- Operator Number
- 2022807
- Address
- 1430 West McCoy Lane, --
- City
- Santa Maria
- State
- CA
- Postal Code
- 93455
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2013-01-07 |
| Culture Media, General Nutrient Broth | JSC | Class 1 | Microbiology | No | 1992-12-09 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2024-08-13 |
| Solution, Isotonic | JCE | Class 1 | Pathology | No | 2013-01-15 |
| Culture Media, Selective Broth | JSD | Class 1 | Microbiology | No | 2001-08-08 |
| Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | JTZ | Class 2 | Microbiology | No | 2022-01-10 |
| Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | JSO | Class 2 | Microbiology | No | 2019-10-18 |
| Culture Media, Selective And Differential | JSI | Class 1 | Microbiology | No | 1992-12-09 |
| Culture Media, For Isolation Of Pathogenic Neisseria | JTY | Class 2 | Microbiology | No | 2013-01-09 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2016-02-01 |
| Basic Fuchsin | KKW | Class 1 | Hematology | No | 2020-09-24 |
| Culture Media, Selective And Non-Differential | JSJ | Class 1 | Microbiology | No | 1992-12-09 |
| Stains, Hematology | KQC | Class 1 | Hematology | No | 2016-08-31 |
| Culture Media, Non-Selective And Differential | JSH | Class 1 | Microbiology | No | 1992-12-09 |
| Culture Media, Enriched | KZI | Class 1 | Microbiology | No | 2012-09-07 |
| Culture Media, Single Biochemical Test | JSF | Class 1 | Microbiology | No | 1992-12-09 |
| Quality Control Slides | LJG | Class 1 | Microbiology | No | 2013-01-07 |
| Gbs Culture Media, Selective And Differential | PQZ | Class 1 | Microbiology | No | 2018-11-26 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 1992-12-09 |
| Culture Media, Multiple Biochemical Test | JSE | Class 1 | Microbiology | No | 1992-12-09 |
| Stains, Microbiologic | JTS | Class 1 | Hematology | No | 2013-01-07 |
Proprietary Names
NALC Powder
Potassium Hydroxide, KOH
Mayer's Albumin
TB Prep Kit, RED
Zephiran-TSP w/BTB Ind.
TB Base Digestant
Triton X-100 10%
SoluPhyte, KOH+DMSO
Sudan Black IV Stain
Oxalic acid 5%
UriStain
MycoMount for wet mounts
Iodine,Dobell & O'Conner
India Ink
TB Prep Kit
MucoGest
Decolorizer, Slow
Water with Tween
Sodium Carbonate, 2N
HCL,50% Concentr. Sol
Deionized Water
Phosphate Buffer
UriStain, 15ml
Sodium Citrte 2.94%
TB Digestant, RED
Std Sampling Soln
Zephiran-TSP
Potassium Hydroxide 10%
Tween 80, 10% Solution
NNN Medium Base
Page's Saline, 2ml
Todd Hewitt Broth
Tryptic Soy Broth
Tryptic Soy Broth, Filtered
Sabdex Broth
Thio w/o Indicator
Alkaline Peptone Water
Phenol Red Broth Base
Brucella Broth
FB Broth
Brain Heart Infusion Broth
AnaeroGro PYG Broth
Thio W/Indicator
Todd Hewitt Br w/0.5%Y Ex
Naegleria Broth
BHI Broth
Page's Saline
Todd Hewitt w/Tween
Nutrient Broth
Viral Transport Medium
TransPRO
Saline 0.45%
Saline 0.85%
MacConkey w/Cipro
Acanthamoeba Broth, 5ml
LIM Broth for GrpB Strep
Selenite Cystine Broth
SIM Medium
MacConkey w/DT
C. auris Enrichment Broth
BHI with Cipro
Lim Broth
Hajna TT Broth
Bile Esculin Azide Broth
Diamonds Medium, Modified
MicroScan HTM BROTH
HardyCHROM CRE
Cetrimide Select Agar
HardyCHROM Candida
MacConkey Agar Deep
EMB Agar (HHT)
Strep B Carrot Broth Kit
HardyCHROM Salmonella
AnaeroGro CCFA
MSA w/Oxacillin
CGB Agar
CLED Agar
Mannitol Salt Agar
DTM Agar Slant
Vogel and Johnson Agar
SP4 Agar w/Arginine
SP4 Broth w/Arginine
Bile Esculin Azide Agar
Baird Parker Agar
Granada Medium
BBE Agar
MacConkey Agar w/Sorbitol
Sulfite Polymyxin Milk Ag
MacConkey Agar (RSR)
A8 for Mycoplasma
BiGGY Agar Slant
SF Broth
Lowenstein Jensen w/Iron
Bile Esculin Agar, BEA
Bile Esculin Agar Slant
CIN (Yersinia) Agar
HardyCHROM Staph aureus
BCSA, for B. cepacia
HardyCHROM Group A Strep Agar
Modified XLD Agar
HardyCHROM Candida + auris
HardyCHROM Campy Agar
AnaeroGro BBE Agar
CLED w/Bile Salts
Derm-DuetTM, RSM
BLUECOLI
SP4 Broth w/Urea
SP4 Agar w/Glucose
HardyCHROM SS NoPRO Agar
MacConkey Agar
BEA with Azide
NaCl 6.5% Broth w/o Ind.
DTM Agar
SS Agar
Leeds Medium
Bile Esculin Agar, Slant
PC Agar
TCBS Agar, for Vibrio
CT-SMAC for E. coli 0157
HE Agar
BCYE w/DGVP
SP4 Broth w/Glucose
Brilliant Green Agar
Bile Esculin Agar
HUrBi
BiGGY Agar
Caffeic Acid Agar
EMB Levine Agar
NaCl 6.5% Broth w/Indic.
MH BROTH with 3% LHB; MicroScan MICroSTREP plus Panels - Linezolid
Martin Lewis w/Lincomycin
Thayer Martin Mod. Agar
Thayer Martin w/VCN
GramPRO 3
Mueller Hinton Agar
Mueller Hinton Broth
Mueller Hinton Agar with Blood
MRSA Screen Plate
Mueller Hinton Agar with Chocolate
Basic Fuchsin
HTM Agar
AnaeroGro LKV Agar
INHIBITORY MOLD AGAR
COL. CNA
MYCOBIOTIC AGAR
AnaeroGro Campy Selective Agar
GN BROTH
V Agar w/CNA
Sabdex Agar w/Chloram.
Middlebrook 7H11 Sel
SabHI Ag w/Bl,Chlor&Cyclo
BCYE Selective Agar w/CAV
Campy CVA Agar
Regan-Lowe Semi Solid
LJ Gruft Slant
Campy Selective Agar
BHI Agar w/Chloramphenicol & Gentamicin
Malt Extract Agar w/01%
Rose Agar (CNA+PEA)
BCYE Selective Agr w/CCVC
LKV Agar
Regan-Lowe Agar
BHI Broth w/Ciprofloxacin
AnaeroGroTM Campy Selective Agar
Peptic Digest Agar w/F&N
M.catarrhalis Sel. Agar
Campy Cefex Agar,Modified
BHI Agar w/Blood & Gent.
Inhib.Mold Agar Slant
Campy,Blood Free, Karmali
Group A Beta Strep Agar
LJ w/NaCl Slant
LJ w/Pyruvate
LJ Media Slant
PDA w/Chloramphenicol
BHI Agar w/Chlr&Cyc
LJ Deep
Malt Extract w/Chloramph.
SabdexAgar w/Chlor&Tetra
Campy Blood Agar
StrePlate
AnaeroGroTM Anaerobic PEA Agar
Columbia CNA Agar
AnaeroGroTM LKV Agar
Campy FDA Agar
BHI Agar w/Bld, Chlr&Gent
Sabdex Agar w/G & C
Potato Flake Select. Agar
PEA w/5% Sheep Blood
PPLO Selective Broth
PPLO Broth
Blood Agar w/Ampicillin
Inhib.Mold Agar w/Genta
Chocolate Agar w/Vanco.
Middlebrook 7H11, Selecti
PPLO Selective Agar
PLET Agar
GBS Detect
Campy Thioglycollate
Chocolate Agar w/Bacitrac
Neomycin Anaerob Bld Agar
Cat. No. W25 Inhib.Mold Agar
Potato Dextrose Agar with TA
Wallenstein Slant
BCYE w/GPVC, 26ml
Inhibitory Mold Agar
LJ Selective Slant
AnaeroGro Anaerobic PEA
Selective Strep Agar
Potato Dextrose Agar with Chloramphenicol
Stanford Potato Agar
CAN Agar
BCYE w/GVPC w/o Cysteine
BCYE w/VPC
CNA w/Esculin Agar
EMMONS SABDEX
HemaPRO Stain Kit
Tryptone Broth 2%
Modified ALP with carbohydrate
Trichophyton #3
Nutrient Gelatin
Pseudomas Isolation Agar
Starch Agar
Trichophyton #4
Nitrate broth with DT
Egg Yolk Agar, Modified
Tech Agar Slant
FID Agar Slant for NFB
Lysine Iron Agar(LIA) Slt
TSB with 6.5% NaCl
AnaeroGro Egg Yolk Agar, modified
KIA Slant
Dermatophyte Milk Agar
Acetate Differential Slnt
Casein Agar
Motility w/TTC Medium
Pseudomonas Agar P
Simmons Citrate Agar Slant
Enteroscreen4 for SS
TSI Agar Slant
Corn Meal Agar w/Tween 80
Esculin Agar Slant
Urea R Broth,1ml
Motility Test Medium
Litmus Milk Broth
Modified ALP with supplement
Motility Test Agar
Nocardia Hydrolysis Kit
Pseudomonas Agar F
Trichophyton #5
Acetamide Agar Slant
Trichophyton #2
AnaeroGroTM Egg Yolk Agar
HardyCHROM UTI
Malonate Broth
Urea Agar Slant
Trichophyton #1
DNAse w/o Indicator
Schaedler Agar w/SB, H&K
Middlebrook 7H11
Chocolate Agar
Blood Agar 5%, EH
Middlebrook 7H10w/HuBlood
Brucella w/H&K
AnaeroGroTM Chopped Meat Gluc. Broth
V Agar, G. vaginalis
BHI Agar w/Blood
Wilkins-Chalgren Agar
Middlebrook 7H9 Broth
Blood Agar 5% (RSR)
BHI Agar w/5% SB
Middlebrook 7H11 Agar
RTF Agar
AnaeroGroTM Chopped Meat Carbo Broth
Columbia Blood Agar
Loefflers Slant
Middlebrook 7H10 Slant
Cooked Meat Medium, 15ml
Regan Lowe w/o Cephalexin
AnaeroGro Brucella Agar w Hemin and Vit K
Middlebrook 7H11 Slant
Thio w/H & K
Tergitol 7 Agar
Blood Agar, 5%
Middlebrook 7H11 Thin Pour
Blood Agar, 8%
BHI Broth w/5% Fildes
Fluid Thio, Enriched
Chocolate Agar Slant
BHI w/H&K
BCYE Agar w/o Cysteine
Blood Agar, 5%, Slant
AnaeroGroTM Chopped Meat Broth
AnaeroGroTM Brucella w/H&K
Blood Agar, 10%
Thio w/Supplements
Cooked Meat w/Iron, H&K
Blood Agar, EH
G. vaginalis Broth
BCYE Agar
Middlebrook 7H10 Agar
Middlebrook 7H9 Broth w/ Tween
Horse Blood Agar, 5%
Middlebrook 7H10
ONPG
Rapid Ornithine
Nitrate Substrate Broth
Motility Nitrate
Trehalose Fermentation Broth
Jordan's Tartrate Deep
Rapid Urea Medium
MGP Broth
OF Medium with carbo
CTA Media
Arylsulfatase
MR-VP Broth
Phenol Red Media
Phenylalanine Agar
LanaGram Rapid bacterial gram reaction Test
Rapid Trehalose Broth
Rapid MGP Media
HardyCHROM MRSA
GramPRO 1 Gram stain control slides
Q-Slide AFB
Q-Slide, Pro bond
Q-Slide-Gram
OF Base Medium
TSA Plate
Potato Flake Agar
Nutrient Agar Plate
Nutrient Agar Slant
Columbia Agar
YM Agar
Agar Deep, 1.5%
Tryptic Soy Agar Slant
Nutrient Agar 1.5%
SabHI Agar
Non-Nutrient Agar
BHI Agar
Potato Dextrose Agar Slant
TSA Slant
Malt Extract Agar
HardyFlask Sabdex Agar
Sabdex Agar
Potato Dextrose Agar
Tryptic Soy Agar
Sabdex Agar, Emmons
Malt Ext Agr w/01% chl
TSA w/6% Yeast Extract
BHI Agar Deep
Sabdex Agar Slant
BHI Agar Slant
TSA Deep
SabHI Agar Slant
MycoVue PFA
Potato Dextrose Agar Deep
Sabdex Agar, Deep
Indole Nitrate Broth
MIL Medium
RSU Broth (sucrose-urea)
MIO Medium
Rapid Anginosus ID Kit
Rapid Urea/Esculin Kit
ONPG-PDA
Strep B Carrot Broth One-Step
GramPRO 1 Reagent Kit
GramPRO 3 Stain Kit
Methylene Blue Stain, Loeffler's 15ml
Hardy Diagnostics Loeffler's 15ml
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)
Remanufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility