FDA Registration
Active
🇺🇸 United States
ANSH LABS, LLC
Reg #: 3008198807
·
FEI: 3008198807
·
Expires 2026
Products
11
Proprietary Names
11
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- ANSH LABS, LLC
- Registration Number
- 3008198807
- FEI Number
- 3008198807
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 445 Medical Center Blvd
- City
- Webster
- State
- TX
- ZIP
- 77598
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN180004
Owner / Operator
- Firm Name
- Ansh Labs, LLC
- Operator Number
- 10041690
- Address
- 445 Medical Center Blvd.
- City
- Webster
- State
- TX
- Postal Code
- 77598
- Country
- US
- Correspondent
- Danielle Kempa
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Glucagon | JME | Class 1 | Clinical Chemistry | No | 2019-01-18 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2021-01-12 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2019-01-18 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2021-01-25 |
| Menopause Test System | QDH | Class 2 | Clinical Chemistry | No | 2018-12-26 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2019-01-18 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 2021-01-12 |
| Enzyme Immunoassay, Inhibin-A | NDR | Class 1 | Clinical Chemistry | No | 2012-08-21 |
| Anti-Müllerian Hormone Test System | PQO | Class 2 | Clinical Chemistry | No | 2022-04-27 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2019-01-18 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 2019-01-18 |
Proprietary Names
Glucagon
AnshCheck Controls
C-Peptide
Prolactin
Menocheck
FSH
Estriol
Inhibin A
AMH
LH
IGF-1
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only