Hardy Diagnostics

FDA Device Registration & Listing · Springboro, OH, US · Registration 3009547954

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009547954
FEI Number
3009547954
Entity Name
Hardy Diagnostics
City/State/Country
Springboro, OH, US
Establishment Address
429 S Pioneer Blvd, Springboro, OH 45066, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
HARDY DIAGNOSTICS (Owner Number: 2022807)
Owner / Operator Contact Address
1430 West McCoy Lane, --, Santa Maria, CA 93455, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Basic Fuchsin 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 Selenite Cystine Broth 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 V Agar w/CNA 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PPM General Purpose Reagent Pathology Class 1 864.4010 2013-01-07
JSC Culture Media, General Nutrient Broth Microbiology Class 1 866.2350 1992-12-09
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2024-08-13
JCE Solution, Isotonic Pathology Class 1 864.4010 2013-01-15
JSD Culture Media, Selective Broth Microbiology Class 1 866.2360 2001-08-08
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2022-01-10
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology Class 2 866.1700 2019-10-18
JSI Culture Media, Selective And Differential Microbiology Class 1 866.2360 1992-12-09
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2022-01-10
JTY Culture Media, For Isolation Of Pathogenic Neisseria Microbiology Class 2 866.2410 2013-01-09
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2016-02-01
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2012-04-24
KKW Basic Fuchsin Hematology Class 1 864.1850 2020-09-24
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology Class 2 866.1700 2022-09-14
JSJ Culture Media, Selective And Non-Differential Microbiology Class 1 866.2360 1992-12-09
KQC Stains, Hematology Hematology Class 1 864.1850 2016-08-31
JSH Culture Media, Non-Selective And Differential Microbiology Class 1 866.2320 1992-12-09
KZI Culture Media, Enriched Microbiology Class 1 866.2330 2012-09-07
JSF Culture Media, Single Biochemical Test Microbiology Class 1 866.2320 1992-12-09
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Microbiology Class 2 866.1700 2011-11-14
LJG Quality Control Slides Microbiology Class 1 866.2660 2013-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HARDY DIAGNOSTICS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2022807 HARDY DIAGNOSTICS Orcutt, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K002664 Hardy Diagnostics HARDYDISK LEVOFLOXACIN, 5MCG 2000-10-26
K790620 Anaerobe Systems LOMBARD DOWELL BROTH MEDIUMW/TH REONINE 1979-04-23
K811056 Acumedia Manufacturers, Inc. BRAIN HEART INFUSION 1981-04-29
K914894 Microtest VIRAPURE, CHLAMYPURE AND MYCOPURE 1991-12-18
K812581 Uti-Tect, Inc. SENSI-TECT 1981-09-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2008 Pml Microbiologicals Inc. 2
Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
Z-0014-2008 Pml Microbiologicals Inc. 2
Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
Z-0043-2012 EMD Chemicals Inc. 1
Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.
Z-0024-05 Remel, Inc. 1
Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009547954. Last updated year: 2026. Please use registration number 3009547954 when referencing this establishment in official correspondence.
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