Identity
- Trade Name
- LIQUID DAB, CHROMOGEN FDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Model / Reference
- HK124-100K FDA UDI
Identifiers
- Catalog Number
- HK124-100K FDA UDI
- Primary DI / UDI-DI
- 00810119677532 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry 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
Category: Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
Liquid Dab, Chromogen by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry.
- TintoPolyDetector Plus Brown Detection Kit (300 Test) — BIO SB, INC. · Class I
- PNI Carcinoma MultiDetector Detection Systems kits — BIO SB, INC. · Class I
- Mohs Mouse/Rabbit PolyDetector DAB HRP Brown Detection System — BIO SB, INC. · Class I
- IHC — Slmp, LLC · Class I
- Mouse/Rabbit PolyDetector DAB HRP Brown Detection System — BIO SB, INC. · Class I
- Mouse/Rabbit PolyDetector DAB HRP Brown Detection System — BIO SB, INC. · Class I
- Mouse/Rabbit ImmunoDetector DAB HRP Brown — BIO SB, INC. · Class I
- Tissue-Tek Genie® PRO — Sakura Finetek USA, Inc · 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
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 77098603-4102-4fe1-9f35-1683953b0c67 35 fields · synced Jun 1, 2026