4+ Universal AP Detection
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- 4plus Universal AP Detection EUDAMED4+ Universal AP Detection FDA UDI
- Generic Name
- Streptavidin-enzyme conjugate reagent IVD FDA UDI
- Device Name
- LSAB (Streptavidin) Detection Systems for IHC EUDAMEDAlternate name : 4plus Streptavidin HRP Label FDA UDI
- Model / Reference
- AP506US EUDAMEDFDA UDILSAB (Streptavidin) Detection Systems for IHC EUDAMED
- Description
- Alternate name : 4plus Streptavidin HRP Label FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627003812 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BLSABKE EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Streptavidin-enzyme conjugate reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Italy 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: Streptavidin-enzyme conjugate reagent IVD
4+ Universal AP Detection by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Streptavidin-enzyme conjugate reagent IVD.
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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 0bdcea80-52d2-4f7d-b2ed-60046757004c 34 fields · synced Jun 19, 2026
- EUDAMED 6e55c316-8816-450d-8df2-a5f65d0ef719 61 fields · synced Jun 19, 2026