Identity
- Trade Name
- BD Kiestra™ InoqulA FDA UDI
- Generic Name
- Microbial specimen inoculation/streaking/colony-picking instrument IVD FDA UDI
- Device Name
- BD Kiestra™ InoqulA FDA UDI
- Model / Reference
- 446973 FDA UDI
- Description
- BD Kiestra™ InoqulA FDA UDI
Identifiers
- Catalog Number
- 446973 FDA UDI
- Primary DI / UDI-DI
- 00382904469733 FDA UDI
- FDA Product Code
- JTC FDA UDI
- GMDN Term
- Microbial specimen inoculation/streaking/colony-picking instrument IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2500 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
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
Category: Microbial specimen inoculation/streaking/colony-picking instrument IVD
BD Kiestra™ InoqulA by BD Kiestra B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microbial specimen inoculation/streaking/colony-picking instrument IVD.
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- ASFA SPOTTER — MBD CO., Ltd. · Class I
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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- BD Kiestra B.V.
Sources (1)
- FDA UDI b794e32a-a60e-4361-9b16-8e8d262d0176 35 fields · synced May 30, 2026