← Back to catalogue
Hi-Di™ Formamide Dx (5 mL)
EUDAMEDFDA UDIClass A (EU MDR)
Ref 4404307 (4440752)
Identity
- Trade Name
- Hi-Di™ Formamide Dx (5 mL) EUDAMEDHi-Di™ Formamide, 3500 Dx Series FDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, reagent FDA UDI
- Device Name
- Hi-Di™ Formamide, a part of Genetic Analyzer Reagents and Consumables EUDAMEDBTL,HI-DI FORMAMIDE 5ML DX FDA UDI
- Model / Reference
- 4404307 (4440752) EUDAMED4404307 FDA UDI
- Description
- BTL,HI-DI FORMAMIDE 5ML DX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302000192 EUDAMEDFDA UDI
- Basic UDI-DI
- 019030244043079P EUDAMED
- FDA Product Code
- PCA FDA UDI
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
- GMDN Term
- Nucleic acid hybridization detection IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Hi-Di™ Formamide Dx (5 mL) by Life Technologies Holdings Pte Ltd. — 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 | 019030244043079P | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED dfa10535-d1f7-4334-ac0a-24d13d52a804 61 fields · synced Jun 19, 2026
- FDA UDI 679e7790-72af-476b-b8e8-2803535ccf61 33 fields · synced May 30, 2026