Identity
- Trade Name
- Drew Scientific FDA UDI
- Generic Name
- Hepatitis B virus e-antigen total antibody IVD, calibrator FDA UDI
- Device Name
- DS5 HbA1c Calibrator (1 and 2) (2 x 4 x 0.5mL) FDA UDI
- Model / Reference
- 014-380SA FDA UDI
- Description
- DS5 HbA1c Calibrator (1 and 2) (2 x 4 x 0.5mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274020210 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Hepatitis B virus e-antigen total antibody IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hepatitis B virus e-antigen total antibody IVD, calibrator
Drew Scientific by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus e-antigen total antibody IVD, calibrator.
- Drew Scientific — Drew Scientific , Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 9c7c7f3c-98e3-4b9e-aca3-ccbc9d57cea5 35 fields · synced May 30, 2026