Identity
- Trade Name
- Kiestra EUDAMEDBD Kiestra™ InoqulA+™ TLA FDA UDI
- Generic Name
- Microbial specimen inoculation/streaking/colony-picking instrument IVD FDA UDI
- Device Name
- BD Kiestra™ InoqulA EUDAMEDBD Kiestra™ InoqulA+™ TLA FDA UDI
- Model / Reference
- 447213 EUDAMEDFDA UDI
- Description
- BD Kiestra™ InoqulA+™ TLA FDA UDI
Identifiers
- Catalog Number
- 447213 FDA UDI
- Primary DI / UDI-DI
- 00382904472139 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290LSUVLPKFPV EUDAMED
- Direct Marketing DI
- 00382904472139 EUDAMED
- FDA Product Code
- JTC FDA UDI
- EMDN Code
- W020305 PLATES STREAKING EQUIPMENT (STREAKER/ INCUBATOR/ READER) EUDAMED
- GMDN Term
- Microbial specimen inoculation/streaking/colony-picking instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2500 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Kiestra by BD Kiestra B.V. — 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 | 038290LSUVLPKFPV | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- BD Kiestra B.V.
- EUDAMED SRN
- NL-MF-000018863
Sources (2)
- EUDAMED 6d47360e-8a23-4b19-9ef1-5f24503aba18 61 fields · synced May 29, 2026
- FDA UDI 6d8fedb1-225d-4aa2-88fb-7b7446b01571 36 fields · synced May 29, 2026