Identity
- Trade Name
- Transonic FDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD FDA UDI
- Model / Reference
- HQD3FME FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00877466001779 FDA UDI
- 510(k) Number
- K872048 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2100 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Metabolic profile clinical chemistry analyser IVD
Transonic by Transonic Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metabolic profile clinical chemistry analyser IVD.
- EPOC HOST, CA, REFURBISHED — Epocal Inc · Class II
- EPOC HOST, REFURBISHED — Epocal Inc · Class II
- EPOC HOST, RX, CA, REFURBISHED — Epocal Inc · Class II
- HOST 2, EPOC, SIMPLIFIED CHINESE — Epocal Inc · Class II
- EPOC HOST, RX, JAPANESE — Epocal Inc · Class II
- EPOC READER, REFURBISHED — Epocal Inc · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- EPOC READER, REFURBISHED, ROHS COMPLIANT — Epocal Inc · Class II
Cleared under the same submission
K872048 also covers:
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
- Transonic — Transonic Systems Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Transonic Systems Inc.
Sources (1)
- FDA UDI a4fad2fe-191e-4523-a128-4b306a789d58 33 fields · synced May 30, 2026