Identity
- Trade Name
- Syva Emit II Plus 6-Acetylmorphine Assay FDA UDI
- Generic Name
- 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Syva Emit II Plus 6-Acetylmorphine Assay - 115 mL Kit FDA UDI
- Model / Reference
- 10730975 FDA UDI
- Description
- Syva Emit II Plus 6-Acetylmorphine Assay - 115 mL Kit FDA UDI
Identifiers
- Catalog Number
- 9R029UL FDA UDI
- Primary DI / UDI-DI
- 00630414229591 FDA UDI
- 510(k) Number
- K102779 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- 6-Acetyl morphine 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: 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
Syva Emit II Plus 6-Acetylmorphine Assay by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA).
- CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST325 — Carolina Liquid Chemistries Corp. · Class I
- Immunalysis — Immunalysis Corporation · Class II
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- 6-Acetylmorphine Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Pointe 6-Acetylmorphine Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- Immunalysis — Immunalysis Corporation · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 — Carolina Liquid Chemistries Corp. · Class II
- Oral Fluid 6-Acetylmorphine Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
Cleared under the same submission
K102779 also covers:
- Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2 — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3 — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 4 — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus 6-Acetylmorphine Assay — Siemens Healthcare Diagnostics
- Syva® Emit® II Plus 6-Acetylmorphine Assay — 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 9617ab80-0c3b-4428-813a-9fc038565623 37 fields · synced Jun 1, 2026