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
General Purpose Reagent PPM
Culture Media, General Nutrient Broth JSC
Culture Media, Non-Propagating Transport JSM
Solution, Isotonic JCE
Culture Media, Selective Broth JSD
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth JTZ
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar JSO
Culture Media, Selective And Differential JSI
Culture Media, For Isolation Of Pathogenic Neisseria JTY
Slide Stainer, Automated KPA
Basic Fuchsin KKW
Culture Media, Selective And Non-Differential JSJ
Stains, Hematology KQC
Culture Media, Non-Selective And Differential JSH
Culture Media, Enriched KZI
Culture Media, Single Biochemical Test JSF
Quality Control Slides LJG
Gbs Culture Media, Selective And Differential PQZ
Culture Media, Non-Selective And Non-Differential JSG
Culture Media, Multiple Biochemical Test JSE
Stains, Microbiologic JTS

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