Establishments and listings

TSA Deep, Potato Dextrose Agar Slant +29

Hardy Diagnostics · Springboro, US

Manufacture Medical DeviceReg. 3009547954JSG
Proprietary name
TSA Deep, Potato Dextrose Agar Slant, Potato Flake Agar, Columbia Agar, YM Agar, MycoVue PFA, BHI Agar Deep, Nutrient Agar 1.5%, Agar Deep, 1.5%, TSA w/6% Yeast Extract, Nutrient Agar Plate, SabHI Agar Slant, Nutrient Agar Slant, Tryptic Soy Agar Slant, OF Base Medium, BHI Agar Slant, Sabdex Agar Slant, BHI Agar, Potato Dextrose Agar Deep, Sabdex Agar, Emmons, Tryptic Soy Agar, Potato Dextrose Agar, Sabdex Agar, Malt Extract Agar, HardyFlask™ Sabdex Agar, TSA Plate, Non-Nutrient Agar, TSA Slant, Malt Ext Agr w/01% chl, SabHI Agar, Sabdex Agar, Deep
Establishment type
Manufacture Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    JSG
    Created date
    1992-12-09
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Culture Media, Non-Selective And Non-Differential
    Medical specialty description
    Microbiology
    Regulation number
    866.2300
    Device class
    1
Establishments and listings

Basic Fuchsin

Hardy Diagnostics · Springboro, US

Repack or Relabel Medical DeviceReg. 3009547954KKW
Proprietary name
Basic Fuchsin
Establishment type
Repack or Relabel Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    KKW
    Created date
    2020-09-24
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Basic Fuchsin
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1
Establishments and listings

Nitrate Substrate Broth, Phenylalanine Agar +14

Hardy Diagnostics · Springboro, US

Manufacture Medical DeviceReg. 3009547954JSF
Proprietary name
Nitrate Substrate Broth, Phenylalanine Agar, Jordan's Tartrate Deep, CTA Media, Motility Nitrate, ONPG, Phenol Red Media, Rapid Urea Medium, Trehalose Fermentation Broth, MR-VP Broth, Rapid Ornithine, OF Medium with carbo, MGP Broth, Rapid Trehalose Broth, LanaGram™ Rapid bacterial gram reaction Test, Rapid MGP Media
Establishment type
Manufacture Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    JSF
    Created date
    1992-12-09
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Culture Media, Single Biochemical Test
    Medical specialty description
    Microbiology
    Regulation number
    866.2320
    Device class
    1
Establishments and listings

HardyCHROM MRSA

Hardy Diagnostics · Springboro, US

Manufacture Medical DeviceReg. 3009547954JSO
K number
K102922
Proprietary name
HardyCHROM MRSA
Establishment type
Manufacture Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    JSO
    Created date
    2011-11-14
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
    Medical specialty description
    Microbiology
    Regulation number
    866.1700
    Device class
    2
Establishments and listings

MacConkey w/DT, SIM Medium +10

Hardy Diagnostics · Springboro, US

Manufacture Medical DeviceReg. 3009547954JSD
Proprietary name
MacConkey w/DT, SIM Medium, BHI with Cipro, C. auris Enrichment Broth, Hajna TT Broth, Bile Esculin Azide Broth, MacConkey w/Cipro, LIM Broth for GrpB Strep, Acanthamoeba Broth, 5ml, Lim Broth, Selenite Cystine Broth, Diamonds Medium, Modified
Establishment type
Manufacture Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    JSD
    Created date
    2001-08-08
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Culture Media, Selective Broth
    Medical specialty description
    Microbiology
    Regulation number
    866.2360
    Device class
    1
Establishments and listings

HardyCHROM CRE

Hardy Diagnostics · Springboro, US

Manufacture Medical DeviceReg. 3009547954JSO
K number
K190553
Proprietary name
HardyCHROM CRE
Establishment type
Manufacture Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    JSO
    Created date
    2019-10-18
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
    Medical specialty description
    Microbiology
    Regulation number
    866.1700
    Device class
    2
Establishments and listings

MIL Medium, Rapid Anginosus ID Kit +5

Hardy Diagnostics · Springboro, US

Manufacture Medical DeviceReg. 3009547954JSE
Proprietary name
MIL Medium, Rapid Anginosus ID Kit, Rapid Urea/Esculin Kit, MIO Medium, ONPG-PDA, RSU Broth (sucrose-urea), Indole Nitrate Broth
Establishment type
Manufacture Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    JSE
    Created date
    1992-12-09
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Culture Media, Multiple Biochemical Test
    Medical specialty description
    Microbiology
    Regulation number
    866.2320
    Device class
    1
Establishments and listings

NALC Powder, India Ink +27

Hardy Diagnostics · Springboro, US

Repack or Relabel Medical Device +1Reg. 3009547954PPM
Proprietary name
NALC Powder, India Ink, Mayer's Albumin, TB Prep Kit, MycoMount for wet mounts, SoluPhyte, KOH+DMSO, Triton X-100 10%, MucoGest, Potassium Hydroxide 10%, TB Digestant, RED, TB Base Digestant, Tween 80, 10% Solution, Sodium Citrte 2.94%, Oxalic acid 5%, UriStain, Decolorizer, Slow, Sodium Carbonate, 2N, HCL,50% Concentr. Sol, Water with Tween, Deionized Water, Potassium Hydroxide, KOH, UriStain, 15ml, Iodine,Dobell & O'Conner, Sudan Black IV Stain, Zephiran-TSP w/BTB Ind., Std Sampling Soln, TB Prep Kit, RED, Zephiran-TSP, Phosphate Buffer
Establishment type
Repack or Relabel Medical Device, Manufacture Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    PPM
    Created date
    2013-01-07
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    General Purpose Reagent
    Medical specialty description
    Pathology
    Regulation number
    864.4010
    Device class
    1
Establishments and listings

HemaPRO Stain Kit

Hardy Diagnostics · Springboro, US

Repack or Relabel Medical DeviceReg. 3009547954KQC
Proprietary name
HemaPRO Stain Kit
Establishment type
Repack or Relabel Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    KQC
    Created date
    2016-08-31
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Stains, Hematology
    Medical specialty description
    Hematology
    Regulation number
    864.1850
    Device class
    1
Establishments and listings

Strep B Carrot Broth™ One-Step

Hardy Diagnostics · Springboro, US

Manufacture Medical DeviceReg. 3009547954PQZ
K number
K170586
Proprietary name
Strep B Carrot Broth™ One-Step
Establishment type
Manufacture Medical Device
Registration
Registration number
3009547954
FEI number
3009547954
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
Hardy Diagnostics
Address line 1
429 S Pioneer Blvd
City
Springboro
State code
OH
Iso country code
US
Zip code
45066
Owner operator
Firm name
HARDY DIAGNOSTICS
Owner operator number
2022807
Contact address
Address 1
1430 West McCoy Lane
Address 2
--
City
Santa Maria
State code
CA
Iso country code
US
Postal code
93455
Products
  1. Product code
    PQZ
    Created date
    2017-08-21
    Owner operator number
    2022807
    Harmonized identifiers (openFDA)
    Device name
    Gbs Culture Media, Selective And Differential
    Medical specialty description
    Microbiology
    Regulation number
    866.2360
    Device class
    1
    K number
    K170586

26 records share this identifier (an establishment lists each device separately); the first 10 are shown.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.