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Ion PGM™ Dx Library Reagents
EUDAMEDFDA UDIClass A (EU MDR)
Ref A18928 (A25512, A43412, A43413, A43414, A27218)
Identity
- Trade Name
- Ion PGM™ Dx Library Reagents EUDAMEDFDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, reagent FDA UDI
- Device Name
- Ion PGM Dx™ Consumables EUDAMED
- Model / Reference
- A18928 (A25512, A43412, A43413, A43414, A27218) EUDAMEDA18928 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302006125 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302A25512RD EUDAMED
- FDA Product Code
- PFT FDA UDI
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid hybridization detection IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ion PGM™ Dx Library Reagents by Life Technologies Limited — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0190302A25512RD | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Corporation
- EUDAMED SRN
- US-MF-000023929
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (3)
- EUDAMED 7f3b63fa-f42c-48c1-aa2e-99987467f4f2 61 fields · synced Jul 8, 2026
- FDA UDI bac6e76a-6559-4f92-9b85-64e2793de97f 32 fields · synced May 30, 2026
- EUDAMED 7f3b63fa-f42c-48c1-aa2e-99987467f4f2-1 61 fields · synced Jun 10, 2026