FDA Registration
Active
🇺🇸 United States
Sudan Black IV Stain
Reg #: 3009547954
·
FEI: 3009547954
·
Expires 2025
Products
1
Proprietary Names
29
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Hardy Diagnostics
- Registration Number
- 3009547954
- FEI Number
- 3009547954
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 429 S Pioneer Blvd
- City
- Springboro
- State
- OH
- ZIP
- 45066
- Country
- US
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 |
Proprietary Names
Sudan Black IV Stain
Potassium Hydroxide 10%
TB Digestant, RED
SoluPhyte, KOH+DMSO
Mayer's Albumin
UriStain
MucoGest
TB Prep Kit
Std Sampling Soln
TB Prep Kit, RED
Triton X-100 10%
India Ink
Iodine,Dobell & O'Conner
NALC Powder
Tween 80, 10% Solution
Phosphate Buffer
Oxalic acid 5%
Decolorizer, Slow
Water with Tween
Sodium Carbonate, 2N
HCL,50% Concentr. Sol
Deionized Water
Potassium Hydroxide, KOH
UriStain, 15ml
TB Base Digestant
Zephiran-TSP
Zephiran-TSP w/BTB Ind.
MycoMount for wet mounts
Sodium Citrte 2.94%
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device