Identity
- Trade Name
- ORTHOTM Sera Papain FDA UDI
- Generic Name
- Papain immunohaematology reagent IVD FDA UDI
- Device Name
- For in vitro diagnostic use only. For use as an enzyme solution with ORTHO™ Sera Anti-Lea, Anti-Leb, Anti-Jka and Anti-Jkb Blood Grouping Reagents. The ORTHO™ Sera Papain is used to enhance reactivity of ORTHO™ Sera red blood cell antigen typing reagents and red blood cells when used in in vitro immunohematology assays. FDA UDI
- Model / Reference
- 6904840 FDA UDI
- Description
- For in vitro diagnostic use only. For use as an enzyme solution with ORTHO™ Sera Anti-Lea, Anti-Leb, Anti-Jka and Anti-Jkb Blood Grouping Reagents. The ORTHO™ Sera Papain is used to enhance reactivity of ORTHO™ Sera red blood cell antigen typing reagents and red blood cells when used in in vitro immunohematology assays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10758750030330 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
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Papain immunohaematology reagent IVD
ORTHOTM Sera Papain by Alba Bioscience Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Papain immunohaematology reagent IVD.
- Papain — DIAGAST · Class II
- IH-Papain — Bio-Rad Medical Diagnostics GmbH · Class II
- ALBAzyme™ Papain Solution Kit — 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
- Alba Bioscience Limited
Sources (1)
- FDA UDI 3a904d82-384f-4e83-a273-e111726c552d 35 fields · synced Jun 8, 2026