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Carezyme I: Trypsin Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TRP955KHModel Enzyme Retrieval Reagents for IHC
Identity
- Trade Name
- Carezyme I: Trypsin Kit, 25 mL EUDAMEDCarezyme I: Trypsin Kit FDA UDI
- Generic Name
- Trypsin IVD, reagent FDA UDI
- Device Name
- Enzyme Retrieval Reagents for IHC EUDAMED
- Model / Reference
- TRP955KH EUDAMEDFDA UDIEnzyme Retrieval Reagents for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627012586 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BENZRETRS EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Trypsin IVD, reagent 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Trypsin IVD, reagent
Carezyme I: Trypsin Kit by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Trypsin IVD, reagent.
- TRYPSIN 3-PACK KIT — Biogenex Laboratories, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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 01fa3940-9f3e-4e91-ae1d-fb5f867f1ad5 33 fields · synced Aug 2, 2026
- EUDAMED 2dc209e7-b8e9-4b86-a030-ecbe2e7f233d 61 fields · synced Aug 2, 2026