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Carezyme II: Pepsin
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref PEP956LModel Enzyme Retrieval Reagents for IHC
Identity
- Trade Name
- Carezyme II: Pepsin, 100 mL EUDAMEDCarezyme II: Pepsin FDA UDI
- Generic Name
- Pepsin IVD, reagent FDA UDI
- Device Name
- Enzyme Retrieval Reagents for IHC EUDAMED
- Model / Reference
- PEP956L EUDAMEDFDA UDIEnzyme Retrieval Reagents for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627010537 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BENZRETRS EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Pepsin IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Sweden 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
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: Pepsin IVD, reagent
Carezyme II: Pepsin by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pepsin IVD, reagent.
- NeoPATH Pro Pepsin — BIOCARE MEDICAL, LLC · Class I
- Carezyme II: Pepsin — BIOCARE MEDICAL, LLC · Class I
- intelliPATH FLX™ Pepsin — BIOCARE MEDICAL, LLC · 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 5754471e-d1bd-4c98-9e62-029caddde179 33 fields · synced Jul 19, 2026
- EUDAMED 398e79f4-ef5f-4bdc-9095-aab74ac4914b 61 fields · synced Jul 19, 2026