Identity
- Trade Name
- R. STM Pack 4 WELL FDA UDI
- Generic Name
- Smooth muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- 3001 FDA UDI
Identifiers
- Catalog Number
- 3001 FDA UDI
- Primary DI / UDI-DI
- 00813545020378 FDA UDI
- FDA Product Code
- DBE FDA UDI
- GMDN Term
- Smooth muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Smooth muscle antibody IVD, kit, fluorescent immunoassay
R. STM Pack 4 WELL by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Scimedx Corp.
Sources (1)
- FDA UDI 7a612671-fb3e-4394-8b95-6bd8db26835f 34 fields · synced May 31, 2026