Identity
- Trade Name
- Kreatech FISH probes FDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, probe FDA UDI
- Model / Reference
- KI-20009B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718858481330 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Nucleic acid hybridization detection IVD, probe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nucleic acid hybridization detection IVD, probe
A comprehensive medical device directory, featuring the Kreatech FISH probes. This probe is designed for nucleic acid hybridization detection in clinical specimens.
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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
- Kreatech Biotechnology B.V.
Sources (1)
- FDA UDI c8075ddc-3c26-4f4c-8c5c-171fef12b6e4 35 fields · synced Jul 25, 2026