Identity
- Trade Name
- Bolt (CLIA) FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- Bolt EIA-CLIA (refurbished) FDA UDI
- Model / Reference
- 00500-CLR FDA UDI
- Description
- Bolt EIA-CLIA (refurbished) FDA UDI
Identifiers
- Catalog Number
- 00500-CLR FDA UDI
- Primary DI / UDI-DI
- B35000500CLR0 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chemiluminescent immunoassay analyser IVDEnzyme immunoassay (EIA) analyser IVD
Bolt (CLIA) by Gold Standard Diagnostics, LLC — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (2)
- FDA UDI abf5f627-40e3-462a-9e5f-45aaba729985 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026