Identity
- Trade Name
- Syva® Emit® II Plus Buprenorphine Assay FDA UDI
- Generic Name
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Syva® Emit® II Plus Buprenorphine Assay - 1L kit FDA UDI
- Model / Reference
- 10720046 FDA UDI
- Description
- Syva® Emit® II Plus Buprenorphine Assay - 1L kit FDA UDI
Identifiers
- Catalog Number
- 9S129UL FDA UDI
- Primary DI / UDI-DI
- 00630414601106 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 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: Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Buprenorphine Assay by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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
- 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI d6c1f531-2389-4e43-8b4d-33ab1eb613d5 37 fields · synced May 30, 2026