Identity
- Trade Name
- Simplexa™ Spectral Calibration Panel FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
- Model / Reference
- SC1100 FDA UDI
Identifiers
- Catalog Number
- SC1100 FDA UDI
- Primary DI / UDI-DI
- 20816101025101 FDA UDI
- 510(k) Number
- K102314 FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
Classification
- 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
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
Category: Optical laboratory instrument performance standard calibrator/control IVD, reusable
Simplexa™ Spectral Calibration Panel by DiaSorin Molecular LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Optical laboratory instrument performance standard calibrator/control IVD, reusable.
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Cleared under the same submission
K102314 also covers:
- Direct Amplification Disc — DiaSorin Molecular LLC
- Direct Amplification Disc — DiaSorin Molecular LLC
- Direct Amplification Disc Kit — DiaSorin Molecular LLC
- Integrated Cycler (220V) — DiaSorin Molecular LLC
- Integrated Cycler (220V) Pre-Owned — DiaSorin Molecular LLC
- Integrated Cyler (110V) — DiaSorin Molecular LLC
- Integrated Cyler (110V) Pre-Owned — DiaSorin Molecular LLC
- Universal Disc — DiaSorin Molecular LLC
- Universal Disc — DiaSorin Molecular LLC
- Universal Disc Cover Tape — DiaSorin Molecular LLC
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI 40da8437-b28f-4290-a6f4-0cfba09a55ea 36 fields · synced Jun 9, 2026