Identity
- Trade Name
- IMMULITE® Systems Dualcount™ Ascorbic Acid FOL FDA UDI
- Generic Name
- Folate (vitamin B9) IVD, reagent FDA UDI
- Device Name
- Ascorbic acid for red cell folic acid determinations with IMMULITE(R) FDA UDI
- Model / Reference
- 10485435 FDA UDI
- Description
- Ascorbic acid for red cell folic acid determinations with IMMULITE(R) FDA UDI
Identifiers
- Catalog Number
- 10485435 FDA UDI
- Primary DI / UDI-DI
- 00630414570587 FDA UDI
- FDA Product Code
- CGN FDA UDI
- GMDN Term
- Folate (vitamin B9) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1295 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Folate (vitamin B9) IVD, reagent
IMMULITE® Systems Dualcount™ Ascorbic Acid FOL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Folate (vitamin B9) IVD, reagent.
- ARCHITECT — ABBOTT IRELAND · Class II
- Elecsys Folate RBC Hemolyzing Reagent — Roche Diagnostics Corp. · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- ADVIA Centaur® FOL Ascorbic Acid Diluent DIL — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K010050 also covers:
- ADVIA Centaur® FOL — Siemens Healthcare Diagnostics
- ADVIA Centaur® FOL — Siemens Healthcare Diagnostics
- ADVIA Centaur® FOL — Siemens Healthcare Diagnostics
- ADVIA Centaur® FOL (25-pack) — Siemens Healthcare Diagnostics
- ADVIA Centaur® FOL Ascorbic Acid Diluent DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® FOL DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® FOL DTT/Releasing Agent — Siemens Healthcare Diagnostics
- ADVIA Centaur® FOL MCM — 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 4877e0a2-2e2d-44a6-a454-989f92d6fc6e 37 fields · synced Jun 6, 2026