Avidin Biotin Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Avidin-Biotin Kit, 500mL EUDAMEDAvidin Biotin Kit FDA UDI
- Generic Name
- Immunohistochemistry endogenous avidin/biotin dual blocking reagent IVD FDA UDI
- Device Name
- Avidin-Biotin Blocking Reagents EUDAMEDAlternate name : Avidin-Biotin Kit FDA UDI
- Model / Reference
- AB972M EUDAMEDFDA UDIAvidin-Biotin Blocking Reagents EUDAMED
- Description
- Alternate name : Avidin-Biotin Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627002501 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BAVBKBRL6 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry endogenous avidin/biotin dual blocking reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Immunohistochemistry endogenous avidin/biotin dual blocking reagent IVD
Avidin Biotin Kit by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Immunohistochemistry endogenous avidin/biotin dual blocking reagent IVD.
- Genemed® — Sakura Finetek USA, Inc · Class I
- ENDOGENOUS BIOTIN BLOCKING KIT — Ventana Medical Systems · Class I
- AVIDIN BIOTIN BLOCKING KIT — Biogenex Laboratories, Inc. · Class I
- Avidin Biotin Kit — BIOCARE MEDICAL, LLC · Class I
- Avidin Biotin Kit — BIOCARE MEDICAL, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (2)
- FDA UDI f37e3cde-9ba9-4f48-b4a7-8501dd01630e 34 fields · synced Jul 9, 2026
- EUDAMED 67069120-140b-402c-89e9-e83f03f32ca3 61 fields · synced Jul 9, 2026