FDA Registration
Active
🇳🇿 New Zealand
CANTERBURY SCIENTIFIC LTD.
Reg #: 3003982601
·
FEI: 3003982601
·
Expires 2026
Products
3
Proprietary Names
10
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CANTERBURY SCIENTIFIC LTD.
- Registration Number
- 3003982601
- FEI Number
- 3003982601
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 71 Whiteleigh Avenue, Addington
- City
- Christchurch Canterbury
- Country
- NZ
Regulatory Submissions
- 510(k) Number
- K053031
Owner / Operator
- Firm Name
- CANTERBURY SCIENTIFIC LTD.
- Operator Number
- 9051098
- Address
- 71 Whiteleigh Avenue, Addington
- City
- Christchurch
- State
- Canterbury
- Postal Code
- 8011
- Country
- NZ
- Correspondent
- Clive Seymour
US Agent
- Business Name
- QSERVE Group US INC.
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Control, Hemoglobin, Abnormal | JCM | Class 2 | Hematology | No | 2008-01-17 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-09-24 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2018-09-24 |
Proprietary Names
Hb FASC
Uni-HbA1cA, Uni-HbA1cN
Tosoh Bioscience Inc. Hemoglobin A1c Controls Levels 1 and 2
Siemens DCA Systems Hemoglobin A1C
HbA1cAP, HbA1cNP, HbA1cP Lvl 1-n, HbA1c Lvl 1-n
Liquid HbA1cA, Liquid HbA1cAP, Liquid HbA1cN, Liquid HbA1cNP, Extendsure HbA1c Liquid Controls B12396, Extendsure HbA1c Liquid Controls B12397
Siemens HbA1c Controls Atellica DCA Analyser
HbA1cP Lvl 1-n, HbA1c Lvl 1-n
HBF&A2 1 Cal, HBF&A2 2 Cal with S
HBF+A2 1, HBF+A2 with S, Tosoh Bioscience Inc. Hemoglobin F and A2 Control Levels 1 and 2
Establishment Types
Manufacture Medical Device