FDA Registration
Active
🇺🇸 United States
Glycosylated hemoglobin (HbA1c) Reagent Set
Reg #: 3013660430
·
FEI: 3013660430
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- High Technology, Inc.
- Registration Number
- 3013660430
- FEI Number
- 3013660430
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 20 Alice Agnew Dr
- City
- North Attleboro
- State
- MA
- ZIP
- 02763
- Country
- US
Owner / Operator
- Firm Name
- High Technology, Inc.
- Operator Number
- 10035029
- Address
- 20 Alice Agnew Dr.
- City
- Attleboro Falls
- State
- MA
- Postal Code
- 02763
- Country
- US
- Correspondent
- Gary Titov
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2013-08-08 |
Proprietary Names
Glycosylated hemoglobin (HbA1c) Reagent Set
Hemoglobin A1c Control Set
Fructosamine Reagent Set
Glycohemoglobin Control Set
Glycohemoglobin Reagent Set
Hemoglobin A1c (HbA1c) Calibrator Set
Hemoglobin A1c (HbA1c) Standard Set
Hemoglobin A1c (HbA1c) Reagent Set
Hemoglobin A1c (HbA1c) Control Set
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device