Identity
- Trade Name
- Extraction Kit - 12 buffer containers FDA UDI
- Generic Name
- Clinical specimen extraction buffer IVD FDA UDI
- Model / Reference
- B-CAL-EX12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- EBUHBCALEX120 FDA UDI
- GMDN Term
- Clinical specimen extraction buffer IVD FDA UDI
Classification
- 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
Yes
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: Clinical specimen extraction buffer IVD
Extraction Kit - 12 buffer containers by Bühlmann Laboratories AG — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clinical specimen extraction buffer IVD.
- Extraction Buffer 4X, 225mL Fill — American Laboratory Products Company · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- LIAISON Q.S.E.T. Buffer — Diasorin Inc.
- Easy Stool Extraction Device — American Laboratory Products Company · Class I
- VITROS — Ortho-Clinical Diagnostics · N
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bühlmann Laboratories AG
Sources (1)
- FDA UDI c195ba26-6740-4257-9370-211b2cc0751a 33 fields · synced Jun 8, 2026