FDA Registration Active 🇺🇸 United States

HARDY DIAGNOSTICS

Reg #: 2022807 · FEI: 2022807 · Expires 2026
Products
32
Proprietary Names
527
Establishment Types
5
Classifications
32

Registration Details

Registration Name
HARDY DIAGNOSTICS
Registration Number
2022807
FEI Number
2022807
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1430 WEST MCCOY LN.
City
Orcutt
State
CA
ZIP
93455
Country
US

Regulatory Submissions

510(k) Number
K002662

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
Susceptibility Test Discs, Antimicrobial JTN
Culture Media, Non-Selective And Differential JSH
Culture Media, Single Biochemical Test JSF
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar JSO
Culture Media, For Isolation Of Pathogenic Neisseria JTY
Culture Media, General Nutrient Broth JSC
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth JTZ
Mounting Media LEB
Culture Media, Multiple Biochemical Test JSE
Gbs Culture Media, Selective And Differential PQZ
Monitor, Microbial Growth JTA
Discs, Strips And Reagents, Microorganism Differentiation JTO
Solution, Isotonic JCE
Plasma, Coagulase, Human, Horse And Rabbit JTL
Culture Media, Non-Selective And Non-Differential JSG
Quality Control Slides LJG
Culture Media, Selective And Non-Differential JSJ
Device, General Purpose, Microbiology, Diagnostic LIB
Stains, Microbiologic JTS
Device, Parasite Concentration LKS
Slides, Microscope KEW
Culture Media, Non-Propagating Transport JSM
Culture Media, Selective Broth JSD
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples SAN
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation LON
Culture Media, Selective And Differential JSI
Culture Media, Anaerobic Transport JSL
General Purpose Reagent PPM
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Culture Media, Enriched KZI
Basic Fuchsin KKW
Supplement, Culture Media JSK

Proprietary Names

HardyDisk Clindamycin HEMOPHILUS ID QUAD PLATE HardyDisk Aztreonam/Avibactam HardyDisk Sulfamethoxazole/Trimethoprim HardyDisk Sulfmethanoxazole.Trimeth 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 HardyDisk Doxycycline HardyDisk Azithromycin HardyDisk Imipenem HardyDisk Gepotidacin BHI Agar w/Vancomycin HardyDisks AST Ceftazidime/Avibactam HardyDisk Piperacillin/Tazobac HardyDisk Cefotaxime Martin Lewis w/Lincomycin Thayer Martin Mod. Agar Thayer Martin w/VCN 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 HardyCHROM ESBL Mueller Hinton Agar Mueller Hinton Broth Mueller Hinton Agar with Blood MRSA Screen Plate Mueller Hinton Agar with Chocolate HardyDisk Amoxicillin HardyDisk Amoxicillin/Clavulanic Acid HardyDisk Plazomicin HardyDisk Ofloxacin Immersion Oil AFB Smear Fix Indole Nitrate Broth MIL Medium RSU Broth (sucrose-urea) MIO Medium Rapid Anginosus ID Kit Rapid Urea/Esculin Kit ONPG-PDA HardyDisk Nalidixic Acid HardyDisk Ceftaroline HardyDisk Cefazolin HardyDisk Penicillin HardyDisk Omadacycline HardyDisk Streptomycin Strep B Carrot Broth™ One-Step McFarland Latex Equiv 6 McFarland Latex Equiv 7 McFarland Latex Equiv 5 McFarland Latex Equiv. 0 McFarland Standards Set McFarland Latex Equiv 0.5 McFarland Latex Equiv 4 McFarland Latex Equiv 1 McFarland Latex Equiv 3 Snyder Test Agar McFarland Latex Equiv 2 McFarland Latex Equiv 8 HardyDisk Nitrofurantoin CatScreen™ Moellers Arginine Decarb Saline 0.45% Saline 0.85% HardyDisk Bacitracin HardyDisk Trimehtomprim HardyDisk Trimethoprim HardyDisk Sulfisoxazole HardyDisk Chloramphenicol Coagulase Cryo HardyDisk AST Cefiderocol 30ug (Fdc30) 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 HardyDisk Piperacillin hardydisk ast rezafungin 5µg (rzf5) GramPRO 1 Gram stain control slides Q-Slide AFB Q-Slide, Pro bond Q-Slide-Gram HardyDisk Imipenem/Relebactam HardyDisk Oxacillin HardyDisk Oxicillin Transgrow Granada Medium 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 HardyDisk Cefoxitin HardyDisk Carbenicillin HardyDisk Amikacin HardyDisk Eravacycline HardyDisk Norfloxacin HardyDisk Levofloxacin CarboFerm Neisseria Kit Phosphate buffer AlbiQuick StrepQuick Test Card GlabrataQuick Kit StrepQuick Kit Phosphate buffered saline 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 GramPRO 1 Reagent Kit GramPRO 3 Stain Kit Methylene Blue Stain, Loeffler's 15ml Hardy Diagnostics Loeffler's 15ml ParaCon Funnel Filter ParaCon Filter Funnels HardyDisk Tigecycline HardyDisk Cefaclor HTM Agar HemaPRO ProBond Slide Pro Slides Microscope Slides Methyl Red Test Reagent Nitrate Reagent A OxiStrips, oxidase test Catalase Reagent,H2O2 15% PYR Test Kit AFB Nitrate Reagent B OxiDrops, oxidase test Nitrocef Matchbook Indole, DMACA Spot Potassium Hydroxide, KOH Indole, Kovacs Reagent Modified Field's Stain Oxidase Powder CAMP Spot Test Rgnt Nitrate Reagent C Nitrate Reagent B Voges-Proskauer Reagent B AFB Nitrate Reagent A HardyDisk Novobiocin 5ug HardyDisk Kanamycin 1000mcg HardyDisk ONPG HardyDisk X Factor HardyDisk Nitrocef HardyDisk Colistin Sulfate HardyDisk Vancomycin 5ug HardyDisk Blank HardyDisk SPS HardyDisk Bile HardyDisk Optochin HardyDisk XV Factor HardyDisk V Factor HardyDisk ALA HardyDisk Nitrate Catalase Reagent, 3% Indoxyl Acetate Disks HardyDisk Lysostaphin Hippurate Disks PYR Reagent Lactophenol Cotton Blue Ferric Chloride, 10% Germ Tube Cryo, Caffeic Acid Disks Ninhydrin Reagent BlueMount OxiSticks Oxidase Swabs Bile Spot Test Anaerobe Nitrate Rgt B Voges-Proskauer Reagent A HCL,50% Concentr. Sol Anaerobe Nitrate Rgt A HardyDisk Novobiocin Viral Transport Medium TransPRO MacConkey w/Cipro Acanthamoeba Broth, 5ml LIM Broth for GrpB Strep SIM Medium MacConkey w/DT C. auris Enrichment Broth BHI with Cipro Lim Broth Hajna TT Broth Bile Esculin Azide Broth Diamonds Medium, Modified HardyDisk Tetracycline HardyCHROM CRE LifeScale Gram Negative (LSGN) kit HardyDisk Cefotetan HardyDisk Lefamulin Moellers Decarb Base HardyDisk Tobramycin HardyDisk Cefuroxime Fecal Concentrator Kit II Fecal Concentrator Kit HardyDisk Gentamicin HardyDisk Ampicillin/Sublactam HardyDisk Amicillin.Sulbactam HardyDisk Ceftriaxone Moellers Ornithine Decarb 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 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. HardyDisk Erythromycin HardyDisk Erthromycin HardyCHROM MRSA Moellers Lysine Decarb Anaerobic Transport Medium NALC Powder 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 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 Mycoseal HardyDisk Ciprofloxacin HardyDisk Cephalothin 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 HardyDisks AST Ceftolozane/Tazobactam HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) HardyDisk Ampicillin HardyDisk Doripenem HardyDisk Ceftazidime HardyDisk Kanamycin Coliscreen HardyDisk Vancomycin HardyDisk Meropenem/Vaborbactam Strep B Carrot Broth Tiles Middlebrook OADC Bovine Serum Albumin 0.2% Hemin & Vit.K Solution L-Cysteine HCl Soln Middlebrook OADC, 100ml Carbon Dioxide (CO2) Tablet Middlebrook ADC Supplemnt HardyDisk Delafloxacin HardyDisk Clarithromycin

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only