Identity
- Trade Name
- Papain FDA UDI
- Generic Name
- Papain immunohaematology reagent IVD FDA UDI
- Device Name
- Papain is a ready to use stabilized solution of proteolytic enzyme, derived from papaya (Carica papaya), used to treat human red blood cells in immunohematology. Intended to be used with DIAGAST Anti-Lea (LE1) (REF 210541) FDA UDI
- Model / Reference
- 210545 FDA UDI
- Description
- Papain is a ready to use stabilized solution of proteolytic enzyme, derived from papaya (Carica papaya), used to treat human red blood cells in immunohematology. Intended to be used with DIAGAST Anti-Lea (LE1) (REF 210541) FDA UDI
Identifiers
- Catalog Number
- 210545 FDA UDI
- Primary DI / UDI-DI
- 23661562105452 FDA UDI
- FDA Product Code
- KSK FDA UDI
- GMDN Term
- Papain immunohaematology reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Papain immunohaematology reagent IVD
Papain by Diagast — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Papain immunohaematology reagent IVD.
- ALBAzyme™ Papain Solution Kit — ALBA BIOSCIENCE LIMITED · Class II
- IH-Papain — Bio-Rad Medical Diagnostics GmbH · Class II
- ORTHOTM Sera Papain — ALBA BIOSCIENCE LIMITED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagast
Sources (1)
- FDA UDI 523d5e93-b8c3-4f1e-b998-9bb536908b32 36 fields · synced May 30, 2026