Identity
- Trade Name
- Simplexa™ Bordetella Positive Control Pack FDA UDI
- Generic Name
- Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Simplexa™ Bordetella Positive Control Pack FDA UDI
- Model / Reference
- MOL2760 FDA UDI
- Description
- Simplexa™ Bordetella Positive Control Pack FDA UDI
Identifiers
- Catalog Number
- MOL2760 FDA UDI
- Primary DI / UDI-DI
- 20816101025637 FDA UDI
- 510(k) Number
- K173498 FDA UDI
- FDA Product Code
- OZZ FDA UDI
- GMDN Term
- Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3980 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Simplexa™ Bordetella Positive Control Pack by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI 0c310ea7-295f-4332-be2d-beeaeb9ce9a2 38 fields · synced Jun 9, 2026