4+ Biotinylated Universal Goat Link
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- 4plus Biotinylated Universal Goat Link EUDAMED4+ Biotinylated Universal Goat Link FDA UDI
- Generic Name
- Immunohistochemistry conjugated secondary antibody IVD FDA UDI
- Device Name
- LSAB (Streptavidin) Detection Systems for IHC EUDAMEDAlternate name : 4plus Biotinylated Universal Goat Link FDA UDI
- Model / Reference
- GU600L EUDAMEDFDA UDILSAB (Streptavidin) Detection Systems for IHC EUDAMED
- Description
- Alternate name : 4plus Biotinylated Universal Goat Link FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627008350 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BLSABKE EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry conjugated secondary antibody IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany 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
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Immunohistochemistry conjugated secondary antibody IVD
4+ Biotinylated Universal Goat Link by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 39abc5f9-1983-4b5d-86d2-c6e11b1cdde6 34 fields · synced Jul 17, 2026
- EUDAMED 58e4f607-758a-4ae9-b091-ca836bc1c3be 61 fields · synced Jul 17, 2026