Identity
- Trade Name
- Synchron FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, control FDA UDI
- Device Name
- SYNCHRON Systems OP 300 High Urine Control FDA UDI
- Model / Reference
- 474991 FDA UDI
- Description
- SYNCHRON Systems OP 300 High Urine Control FDA UDI
Identifiers
- Catalog Number
- 474991 FDA UDI
- Primary DI / UDI-DI
- 15099590221997 FDA UDI
- 510(k) Number
- K993023 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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: Opiate/opiate metabolite IVD, control
Synchron by Beckman Coulter, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Opiate/opiate metabolite IVD, control.
- Opiate DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- ARK™ Fentanyl Control (WPT) — ARK DIAGNOSTICS INC · Class I
- Pointe Opiates 2000 Level 2 Control (Morphine 2500 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Opiate 2000 DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Opiate 2000 DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Hydrocodone 300 DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Hydrocodone 100 DAU Control, Level 2 Control — Lin-Zhi International, 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
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 43ad088f-504d-4e28-9668-a34eec8e9ad6 35 fields · synced Jun 8, 2026