Identity
- Trade Name
- Kiestra EUDAMEDBD Kiestra™ IdentifA FDA UDI
- Generic Name
- Microbial specimen inoculation/streaking/colony-picking instrument IVD FDA UDI
- Device Name
- BD Kiestra™ IdentifA BD Kiestra™ IdentifA TLA Connection BD Kiestra™ IdentifA WCA Connection BD Kiestra™ Isolate Suspension Cuvette Array BD Kiestra™ IdentifA Manual Infeed EUDAMEDBD Kiestra™ IdentifA FDA UDI
- Model / Reference
- 444060 EUDAMED444061 EUDAMED444063 EUDAMEDFDA UDI
- Description
- BD Kiestra™ IdentifA FDA UDI
Identifiers
- Catalog Number
- 444063 FDA UDI
- Primary DI / UDI-DI
- 00382904440602 EUDAMED00382904440619 EUDAMED00382904440633 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290IZCYQAPNK9 EUDAMED
- Direct Marketing DI
- 00382904440602 EUDAMED00382904440619 EUDAMED00382904440633 EUDAMED
- FDA Product Code
- QBN FDA UDIQQV FDA UDI
- EMDN Code
- W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER EUDAMED
- GMDN Term
- Microbial specimen inoculation/streaking/colony-picking instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3378 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Depth — 860 Millimeter FDA UDIWidth — 1060 Millimeter FDA UDIWeight — 550 Kilogram FDA UDIHeight — 1700 Millimeter FDA UDI
Kiestra by Becton, Dickinson and Company — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290IZCYQAPNK9 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (4)
- EUDAMED 5bee1201-f708-43c4-8c64-056cb2fe428f 61 fields · synced Oct 7, 2026
- EUDAMED 59a1f21f-6c01-4ecc-8887-cb668dfa0bbc 61 fields · synced May 17, 2026
- FDA UDI dde81aa3-1b1c-49a9-b026-f6b0694c5fc7 38 fields · synced May 29, 2026
- EUDAMED 32508daa-529a-4110-80fc-a065e5fa641f 61 fields · synced Jul 8, 2026