Identity
- Trade Name
- Syva® Emit® 2000 Phenobarbital Assay FDA UDI
- Generic Name
- Phenobarbital IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Emit ® 2000 Phenobarbital Assay FDA UDI
- Model / Reference
- 10445306 FDA UDI
- Description
- Emit ® 2000 Phenobarbital Assay FDA UDI
Identifiers
- Catalog Number
- 4D019UL FDA UDI
- Primary DI / UDI-DI
- 00842768017407 FDA UDI
- 510(k) Number
- K913190 FDA UDI
- FDA Product Code
- DLZ FDA UDI
- GMDN Term
- Phenobarbital IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3660 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: Phenobarbital IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Phenobarbital Assay by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phenobarbital IVD, kit, enzyme immunoassay (EIA).
- PHB — Randox Laboratories, Ltd. · Class II
- Emit® 2000 Phenobarbital Assay — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K913190 also covers:
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 4962eeff-d4c2-42a9-9560-a11e90b88960 37 fields · synced May 30, 2026