FDA Registration
Active
🇺🇸 United States
MP BIOMEDICALS DIAGNOSTICS DIVISION
Reg #: 2419955
·
FEI: 2419955
·
Expires 2026
Products
7
Proprietary Names
13
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- MP BIOMEDICALS DIAGNOSTICS DIVISION
- Registration Number
- 2419955
- FEI Number
- 2419955
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 29525 Fountain Pkwy
- City
- Solon
- State
- OH
- ZIP
- 44139
- Country
- US
Regulatory Submissions
- 510(k) Number
- K800126
Owner / Operator
- Firm Name
- MP BIOMEDICALS LLC
- Operator Number
- 9057708
- Address
- 29525 FOUNTAIN PARKWAY
- City
- Solon
- State
- OH
- Postal Code
- 44139
- Country
- US
- Correspondent
- Walter S Zawadzkas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2010-12-17 |
| Radioimmunoassay, Gastrin | CGC | Class 1 | Clinical Chemistry | No | 1995-05-30 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2010-12-17 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2010-12-17 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2010-12-17 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 1996-07-31 |
| Radioimmunoassay, Total Estrogens, Nonpregnancy | JMD | Class 1 | Clinical Chemistry | No | 1996-07-31 |
Proprietary Names
Progesterone DA
17OH-Progesterone DA
Progesterone CT
Gastrin RIA kit
Testosterone DA
Estradiol DA
Free T4 Solid Phase RIA
ImmuChem Androstenedione DA
BE
IMMUCHEM 17B-ESTRADIOL COATED TUBE
IMMUCHEM 17B-ESTRADIOL DOUBLE ANTIB
IMMUCHEM TOTAL ESTROGENS (E1
E2) DOUBLE ANTIBODY
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device