← Back to catalogue
Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 2
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 2 FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 2 FDA UDI
- Model / Reference
- 10720050 FDA UDI
- Description
- Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 2 FDA UDI
Identifiers
- Catalog Number
- 9S549UL FDA UDI
- Primary DI / UDI-DI
- 00630414601144 FDA UDI
- 510(k) Number
- K150606 FDA UDI
- FDA Product Code
- LAS FDA UDIDLJ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI862.3200 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 2 by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Multiple drugs of abuse IVD, calibrator.
- Pointe Multi-Analyte E DAU High Calibrator — POINTE SCIENTIFIC, INC. · Class II
- Preciset DAT Plus I — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Preciset TDM II — Roche Diagnostics Corp. · Class II
- Pointe Hydrocodone 300 Calibrator (800 ng/mL) — POINTE SCIENTIFIC, INC.
- Alinity — Abbott Laboratories, Inc. · Class II
- Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K150606 also covers:
- Syva® Emit® II Plus Buprenorphine Assay — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus Buprenorphine Assay — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus Buprenorphine Assay — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 1 — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 3 — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 4 — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus Specialty Drug Control Negative — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus Specialty Drug Control Positive — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 1e8625ac-4450-45ed-8def-5b34903da80e 37 fields · synced May 31, 2026