FDA Registration
Active
🇺🇸 United States
Mueller Hinton Broth
Reg #: 1924669
·
FEI: 1924669
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- REMEL, INC.
- Registration Number
- 1924669
- FEI Number
- 1924669
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12076 Santa Fe Trail Dr
- City
- LENEXA
- State
- KS
- ZIP
- 66215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K802957
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | JTZ | Class 2 | Microbiology | No | 2011-12-13 |
Proprietary Names
Mueller Hinton Broth
T3462-05 MUELLER-HINTON BROTH W/TES 5ml 100/BOX
CP11410 Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood
T3462 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES
CP112-10 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood
T3491 Sensititre Saline- Tween w/ Glass Beads
T3441 Sensititre Middlebrook 7H9 Broth w/OADC
T8006 Sensititre Cation Adjusted Mueller-Hinton w/ TES w/ OADC
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device