Identity
- Trade Name
- Q-STAIN® QSX Enhancer FDA UDI
- Generic Name
- Immunohistochemistry conjugated secondary antibody IVD FDA UDI
- Model / Reference
- QD28020-004 FDA UDI
Identifiers
- Catalog Number
- QD28020-004 FDA UDI
- Primary DI / UDI-DI
- 00850036867104 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunohistochemistry conjugated secondary antibody IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
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
Dimensions & Sizes
- Size
- Total Volume — 4 Milliliter FDA UDI
Category: Immunohistochemistry conjugated secondary antibody IVD
Q-STAIN® QSX Enhancer by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunohistochemistry conjugated secondary antibody IVD.
- 4+ Biotinylated Goat Anti-Mouse IgG — BIOCARE MEDICAL, LLC · Class I
- intelliPATH FLX™ Multiplex Secondary Reagent 2 — BIOCARE MEDICAL, LLC · Class I
- ULTRAVIEW UNIVERSAL AP RED DETECTION KIT — Ventana Medical Systems · Class I
- 4+ Biotinylated Universal Goat Link — BIOCARE MEDICAL, LLC · Class I
- 4+ Biotinylated Universal Goat Link — BIOCARE MEDICAL, LLC · Class I
- 4+ Biotinylated Goat Anti-Rabbit IgG — BIOCARE MEDICAL, LLC · Class I
- intelliPATH™ Multiplex Secondary Reagent 2 — BIOCARE MEDICAL, LLC · Class I
- 4+ Biotinylated Goat Anti-Rabbit IgG (Ms, Rt) Ads — BIOCARE MEDICAL, LLC · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novodiax, Inc.
Sources (1)
- FDA UDI b9cbc28d-803b-4c8e-b6ae-985ec0737328 36 fields · synced May 30, 2026