Identity
- Trade Name
- OPTIGEN® AP 3600™ Automated Instrument FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- Automated In Vitro Allergy Diagnostic System FDA UDI
- Model / Reference
- 95413 FDA UDI
- Description
- Automated In Vitro Allergy Diagnostic System FDA UDI
Identifiers
- Catalog Number
- 95413 FDA UDI
- Primary DI / UDI-DI
- 00813382010204 FDA UDI
- 510(k) Number
- K182793 FDA UDI
- FDA Product Code
- DHB FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chemiluminescent immunoassay analyser IVD
OPTIGEN® AP 3600™ Automated Instrument by Minaris Medical America, Inc. — 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
- Minaris Medical America, Inc.
Sources (1)
- FDA UDI d60daf39-4097-4f5f-80aa-06c5811136f2 36 fields · synced May 30, 2026