Identity
- Trade Name
- NMIC/ID-313 FDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
- Device Name
- NMIC/ID-313 FDA UDI
- Model / Reference
- 449083 FDA UDI
- Description
- NMIC/ID-313 FDA UDI
Identifiers
- Catalog Number
- 449083 FDA UDI
- Primary DI / UDI-DI
- 30382904490837 FDA UDI
- 510(k) Number
- K020322 FDA UDIK023444 FDA UDIK023634 FDA UDIK023858 FDA UDIK033458 FDA UDIK042932 FDA UDIK060444 FDA UDIK060447 FDA UDIK061327 FDA UDIK061355 FDA UDIK062944 FDA UDIK062945 FDA UDIK063573 FDA UDIK063811 FDA UDIK063824 FDA UDIK132674 FDA UDIK181665 FDA UDIK233986 FDA UDI
- FDA Product Code
- LON FDA UDI
- GMDN Term
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1645 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Nmic/Id-313 by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020322 also covers:
K023444 also covers:
K023634 also covers:
K023858 also covers:
K033458 also covers:
K042932 also covers:
K060444 also covers:
K060447 also covers:
K061327 also covers:
K061355 also covers:
K062944 also covers:
K062945 also covers:
K063573 also covers:
K063811 also covers:
K063824 also covers:
K132674 also covers:
K181665 also covers:
K233986 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 85b5c2d7-e116-4fbc-9e5a-7986d61d2944 37 fields · synced May 30, 2026