Identity
- Trade Name
- Atellica™ IM Fol MCM FDA UDI
- Generic Name
- Folate (vitamin B9) IVD, control FDA UDI
- Device Name
- Folic Acid (Fol) - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL FDA UDI
- Model / Reference
- 10995575 FDA UDI
- Description
- Folic Acid (Fol) - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL FDA UDI
Identifiers
- Catalog Number
- 10995575 FDA UDI
- Primary DI / UDI-DI
- 00630414598994 FDA UDI
- 510(k) Number
- K172201 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Folate (vitamin B9) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Folate (vitamin B9) IVD, control
Atellica™ IM Fol MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Folate (vitamin B9) IVD, control.
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- Lyphochek — Bio-Rad Laboratories · Class I
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- Alinity — ABBOTT IRELAND · Class I
- Lyphochek — Bio-Rad Laboratories · Class I
- ARCHITECT — ABBOTT IRELAND · Class II
Cleared under the same submission
K172201 also covers:
- Atellica IM Fol — Siemens Healthcare Diagnostics
- Atellica™ IM Fol — Siemens Healthcare Diagnostics
- Atellica™ IM Fol — Siemens Healthcare Diagnostics
- Atellica™ IM Fol DIL — Siemens Healthcare Diagnostics
- Atellica™ IM Fol DTT/Releasing Agent — Siemens Healthcare Diagnostics
- Atellica™ IM RBC FOL — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI d75dc038-96bc-4b1d-a3d3-6937aacb5ed9 37 fields · synced May 30, 2026