Identity
- Trade Name
- DxSelect™ - 10X Wash Buffer FDA UDI
- Generic Name
- Immunohistochemistry wash buffer reagent IVD FDA UDI
- Model / Reference
- EL0405 FDA UDI
Identifiers
- Catalog Number
- EL0405 FDA UDI
- Primary DI / UDI-DI
- 10816101022356 FDA UDI
- 510(k) Number
- K993754 FDA UDI
- FDA Product Code
- MXJ FDA UDI
- GMDN Term
- Immunohistochemistry wash buffer reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3305 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Immunohistochemistry wash buffer reagent IVD
DxSelect™ - 10X Wash Buffer by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Immunohistochemistry wash buffer reagent IVD.
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- Immunocare TBS Wash Buffer 10X — BIOCARE MEDICAL, LLC · Class I
- 20% Tween 20 — BIOCARE MEDICAL, LLC · Class I
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Cleared under the same submission
K993754 also covers:
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- DxSelect™ - Substrate Reagent — DiaSorin Molecular LLC
- DxSelect™ Sample Diluent — DiaSorin Molecular LLC
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- HSV-1 ELISA IgG High Positive Control — DiaSorin Molecular LLC
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- HerpeSelect® 1 ELISA IgG — 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI 49a8e3d9-2a60-4877-947a-52e4ea224cdd 36 fields · synced Jun 9, 2026