FDA Registration
Active
🇩🇪 Germany
MACHEREY-NAGEL GMBH & CO., KG.
Reg #: 4580
·
FEI: 4580
·
Expires 2025
Products
12
Proprietary Names
0
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- MACHEREY-NAGEL GMBH & CO., KG.
- Registration Number
- 4580
- FEI Number
- 4580
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Valencienner Str. 11
- City
- DUEREN North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K061742
Owner / Operator
- Firm Name
- MACHEREY-NAGEL GMBH & CO. KG.
- Operator Number
- 9016893
- Address
- Valencienner Str. 11, --
- City
- DUEREN
- State
- DE-NOTA
- Postal Code
- 52355
- Country
- DE
- Correspondent
- Markus - Meusel
US Agent
- Business Name
- MACHEREY-NAGEL INC.
- Contact Name
- DAWN Russup
- Address
- 924 Marcon Blvd. Ste 102
- City
- Allentown
- State
- PA
- ZIP
- 18109
- Country
- US
- [email protected]
- Phone
- 484 8210984
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2005-12-21 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2005-12-21 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2005-12-21 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2005-12-21 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2005-12-21 |
| Blood, Occult, Enzymatic Method, In Urine | JIP | Class 2 | Hematology | No | 2005-12-21 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2005-12-21 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2005-12-21 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2005-12-21 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2005-12-21 |
| Solution, Copper Sulfate For Specific Gravity Determinations | KSL | Class 1 | Hematology | No | 2005-12-21 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2005-12-21 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)