FDA Registration
Active
🇺🇸 United States
SCI MEDIC, INC.
Reg #: 3003791481
·
FEI: 3003791481
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SCI MEDIC, INC.
- Registration Number
- 3003791481
- FEI Number
- 3003791481
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7311 Grove Road Unit L
- City
- FREDERICK
- State
- MD
- ZIP
- 21704
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063295
Owner / Operator
- Firm Name
- SCI MEDIC, INC.
- Operator Number
- 9056701
- Address
- 7311 Grove Road Unit L, --
- City
- Frederick
- State
- MD
- Postal Code
- 21704
- Country
- US
- Correspondent
- VIRGINIA M KENDALL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2025-02-10 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2025-02-10 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2025-09-25 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2019-12-30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2005-04-08 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2020-08-11 |
| Liquid Chromatography, Morphine | DPK | Class 2 | Clinical Toxicology | No | 2021-01-04 |
Proprietary Names
NEW CHOICE
U-CHECK
NEW CHOICE PLUS
Establishment Types
Repack or Relabel Medical Device