FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ORTHOTM Sera Papain
DI: 10758750030330
·
Model: 6904840
·
ALBA BIOSCIENCE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ORTHOTM Sera Papain
- Primary DI
- 10758750030330
- Version / Model
- 6904840
- Company Name
- ALBA BIOSCIENCE LIMITED
- Labeler DUNS
- 516536641
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-30
- Public Version
- 4
- Public Version Date
- 2022-03-31
- Public Version Status
- Update
- Public Device Record Key
- 3a904d82-384f-4e83-a273-e111726c552d
- Distribution End Date
- 2017-09-01
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSK | Solution, Stabilized Enzyme | Hematology | 864.9400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52728 | Papain immunohaematology reagent IVD | A substance or reactant that is a papain enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10758750030330 | GS1 |
Customer Contacts
- Phone
- +41225458274
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius