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Syva® Emit® II Plus Specialty Drug Control Positive
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Syva® Emit® II Plus Specialty Drug Control Positive FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, control FDA UDI
- Device Name
- Syva® Emit® II Plus Buprenorphine Control Positive FDA UDI
- Model / Reference
- 10718701 FDA UDI
- Description
- Syva® Emit® II Plus Buprenorphine Control Positive FDA UDI
Identifiers
- Catalog Number
- 9S619UL FDA UDI
- Primary DI / UDI-DI
- 00630414601090 FDA UDI
- 510(k) Number
- K150606 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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, control
Syva® Emit® II Plus Specialty Drug Control Positive by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple drugs of abuse IVD, control.
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- DAU LC 1 — UTAK LABORATORIES, INC. · Class I
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 2 — 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
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 6222262b-ef2c-4c27-b6da-e7f17774d621 37 fields · synced Jun 8, 2026