Identity
- Trade Name
- accu-beads® FDA UDI
- Generic Name
- Sperm concentration indicator IVD, control FDA UDI
- Device Name
- accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and automated sperm concentration measurements. FDA UDI
- Model / Reference
- accu-beads® FDA UDI
- Description
- accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and automated sperm concentration measurements. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858604006016 FDA UDI
- FDA Product Code
- NRF FDA UDI
- GMDN Term
- Sperm concentration indicator IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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
No
FDA UDI
Category: Sperm concentration indicator IVD, control
accu-beads® by HAMILTON THORNE, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- HAMILTON THORNE, Inc.
Sources (1)
- FDA UDI 08aa9145-b80f-42c5-913f-d379b2f978f1 33 fields · synced May 30, 2026