Identity
- Trade Name
- S.G. Calibrator H FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, AUTION MAX AX-4030 and AUTION MAX AX-4280 Urine Analyzers. The calibration is scheduled to occur monthly or as needed. FDA UDI
- Model / Reference
- 100672 FDA UDI
- Description
- The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, AUTION MAX AX-4030 and AUTION MAX AX-4280 Urine Analyzers. The calibration is scheduled to occur monthly or as needed. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987486001959 FDA UDI
- 510(k) Number
- K013783 FDA UDI
- FDA Product Code
- JMT FDA UDI
- GMDN Term
- Urine analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine analyser IVD, laboratory
S.G. Calibrator H by Arkray Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine analyser IVD, laboratory.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Uri-Trak 120 Analyzer — STANBIO LABORATORY, L.P. · Class I
- Urisys 1100 Urine Analyzer — Roche Diagnostics Corp. · Class II
- UA Win10 Kit — BECKMAN COULTER IRELAND INC. · Class I
- Moore Medical — Moore Medical Corp. · Class II
- Moore Medical — Moore Medical Corp. · Class II
- iChem Velocity — BECKMAN COULTER IRELAND INC. · Class I
- iChem® VELOCITY™ — BECKMAN COULTER IRELAND INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arkray Usa, Inc.
Sources (1)
- FDA UDI fb1202f6-6985-4a4d-9eda-826a28ef36b4 36 fields · synced May 31, 2026