Identity
- Trade Name
- BC+™ FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, no additive FDA UDI
- Device Name
- 12x80 mm vacuum tube for positive blood culture FDA UDI
- Model / Reference
- 2U026S FDA UDI
- Description
- 12x80 mm vacuum tube for positive blood culture FDA UDI
Identifiers
- Catalog Number
- 2U026S FDA UDI
- Primary DI / UDI-DI
- 18053326004534 FDA UDI
- FDA Product Code
- KDT FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, no additive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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: Evacuated blood collection tube IVD, no additive
Bc+™ by Copan Italia Spa — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Evacuated blood collection tube IVD, no additive.
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- Vacuette — Greiner Bio-One GmbH · Class II
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- Vacuette — Greiner Bio-One GmbH · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
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
- Copan Italia Spa
Sources (2)
- FDA UDI 6c84756d-e7a1-405d-8b73-6557b199846f 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026