Syva® Emit® Calibrator Level 0 (negative)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Emit Calibrator Level 0 (negative) EUDAMEDSyva® Emit® Calibrator Level 0 (negative) FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_B_REAG_Calibrator Level 0 (negative) EUDAMEDSyva® Emit® Calibrator Level 0 (negative) FDA UDI
- Model / Reference
- 10445403 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_B_REAG_Calibrator Level 0 (negative) EUDAMED
- Description
- Syva® Emit® Calibrator Level 0 (negative) FDA UDI
Identifiers
- Catalog Number
- 9A049UL FDA UDI
- Primary DI / UDI-DI
- 00842768001703 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901073V5 EUDAMED
- 510(k) Number
- K902581 FDA UDI
- FDA Product Code
- DKB FDA UDI
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Multiple drugs of abuse IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator Level 0 (negative) by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 9e9cdf56-05f4-4ac0-baba-7076b6fb5028 37 fields · synced Oct 6, 2026
- EUDAMED 351ad1a0-9707-42cb-b5b7-7802756f8b6b 61 fields · synced Sep 17, 2026