Identity
- Trade Name
- Synermed® FDA UDI
- Generic Name
- Iron IVD, reagent FDA UDI
- Device Name
- Serum Iron Reagent 4 X 50 mL + 2 X 29 mL FDA UDI
- Model / Reference
- IR320-911 FDA UDI
- Description
- Serum Iron Reagent 4 X 50 mL + 2 X 29 mL FDA UDI
Identifiers
- Catalog Number
- IR320-911 FDA UDI
- Primary DI / UDI-DI
- 05060500091019 FDA UDI
- 510(k) Number
- K912912 FDA UDI
- FDA Product Code
- CFM FDA UDI
- GMDN Term
- Iron IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1410 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Iron IVD, reagent
Synermed® by Infrared Laboratory Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Iron IVD, reagent.
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- ACE — Alfa Wassermann, Inc. · Class I
- ClearChem Diagnostics Inc. Iron — CLEARCHEM DIAGNOSTICS INC. · Class I
- Pointe Scientific Inc. Iron — POINTE SCIENTIFIC, INC. · Class I
- Iron Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
Cleared under the same submission
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
- Infrared Laboratory Systems Llc
Sources (1)
- FDA UDI 56e5090e-3bea-48ad-bb5d-46f188041656 37 fields · synced Jun 1, 2026