Identity
- Trade Name
- NOVEOS Wash Buffer Concentrate Pack FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Model / Reference
- 63165Z FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816879029512 FDA UDI
- 510(k) Number
- K182479 FDA UDI
- FDA Product Code
- DHB FDA UDIJJE FDA UDI
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 FDA UDI862.2160 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
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: Buffered wash solution IVD
NOVEOS Wash Buffer Concentrate Pack by Hycor Biomedical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered wash solution IVD.
- ADVIA Centaur® Wash 1 — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® PW3 — Siemens Healthcare Diagnostics · Class I
- CELL-DYN — Abbott Laboratories, Inc. · Class I
- VENTANA HE 600 Wash — Ventana Medical Systems · Class I
- TBS Auto Wash Buffer 20X — BIOCARE MEDICAL, LLC · Class I
- ADVIA Centaur® PW 4 — Siemens Healthcare Diagnostics · Class I
- COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
- ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
Cleared under the same submission
K182479 also covers:
- NOVEOS Conjugate IgE — HYCOR BIOMEDICAL LLC
- NOVEOS Conjugate IgE — HYCOR BIOMEDICAL LLC
- NOVEOS Cuvette Wash Pack — HYCOR BIOMEDICAL LLC
- NOVEOS Diluent A Kit — HYCOR BIOMEDICAL LLC
- NOVEOS Diluent A Kit — HYCOR BIOMEDICAL LLC
- NOVEOS Fluo Beads — HYCOR BIOMEDICAL LLC
- NOVEOS Fluo Beads — HYCOR BIOMEDICAL LLC
- NOVEOS House Dust Mite, Dermatophagoides pteronyssinus — HYCOR BIOMEDICAL LLC
- NOVEOS House Dust Mite, Dermatophagoides pteronyssinus — HYCOR BIOMEDICAL LLC
- NOVEOS IgE Calibrator Antibody Pack — HYCOR BIOMEDICAL LLC
- NOVEOS IgE Calibrator Antibody Pack — HYCOR BIOMEDICAL LLC
- NOVEOS IgE Calibrator Set — HYCOR BIOMEDICAL 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hycor Biomedical Llc
Sources (1)
- FDA UDI 18c36800-b890-497e-b365-4cccb37cf28b 35 fields · synced May 30, 2026