FDA Registration
Active
🇺🇸 United States
SALIMETRICS LLC.
Reg #: 3003760091
·
FEI: 3003760091
·
Expires 2026
Products
7
Proprietary Names
14
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- SALIMETRICS LLC.
- Registration Number
- 3003760091
- FEI Number
- 3003760091
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 101 INNOVATION BLVD STE 302
- City
- State College
- State
- PA
- ZIP
- 16803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031348
Owner / Operator
- Firm Name
- SALIMETRICS LLC.
- Operator Number
- 9045886
- Address
- 101 INNOVATION BLVD., STE. 302, --
- City
- State College
- State
- PA
- Postal Code
- 16803
- Country
- US
- Correspondent
- Mark Hollerbach
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2006-09-05 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2024-05-23 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2005-08-29 |
| Enzyme Immunoassay, Cortisol, Salivary | NHG | Class 2 | Clinical Chemistry | No | 2007-11-08 |
| Enzyme Immunoassay, Nicotine And Nicotine Metabolites | MKU | Class 1 | Clinical Toxicology | No | 2012-02-29 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2013-04-08 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2006-09-05 |
Proprietary Names
Swab Storage Tube
Saliva Collection Aid (SCA)
Saliva Collection Aid 96 Well Format
CRYOVIAL
Salimetrics Salivary Insulin ELISA Kit
Salivary Progesterone Enzyme Immunoassay kit
Expanded Range High Sensitivity Salivary Cortisol Enzyme immunoassay Kit
High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit
High Sensitivity Salivary 17beta-Estradiol Enzyme Immunoassay Kit
Expanded Sensitivity Salivary 17beta-Estradiol Enzyme Immunoassay Kit
Salimetrics Infant's Swab
Salimetrics Oral Swab
Salimetrics Children's Swab
Salimetrics Swab Oral Fluid/Saliva Collection Device
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility