Identity
- Trade Name
- ACD FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, probe FDA UDI
- Device Name
- Analyte Specific Reagent. Analytical and performance characteristics are not established. FDA UDI
- Model / Reference
- RS7750 FDA UDI
- Description
- Analyte Specific Reagent. Analytical and performance characteristics are not established. FDA UDI
Identifiers
- Catalog Number
- RS7750 FDA UDI
- Primary DI / UDI-DI
- 05055331327826 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) nucleic acid 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
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
Category: Cytomegalovirus (CMV) nucleic acid IVD, probe
Acd by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) nucleic acid IVD, probe.
- BOND — Leica Biosystems Newcastle, Limited · Class I
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
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 477195c1-7bd7-4d4f-82cc-1753d5138d7a 36 fields · synced May 30, 2026