FDA UDI
In Commercial Distribution
🇺🇸 United States
CAPI 3 NEONAT HEMOLYSING SOLUTION
DI: 03607360025635
·
Model: 2563
·
SEBIA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CAPI 3 NEONAT HEMOLYSING SOLUTION
- Primary DI
- 03607360025635
- Version / Model
- 2563
- Catalog Number
- 2563
- Company Name
- SEBIA
- Labeler DUNS
- 276801933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-30
- Public Version
- 1
- Public Version Date
- 2024-05-08
- Public Version Status
- New
- Public Device Record Key
- 25d1c6b9-cecc-4d69-bd6c-ce8df1fdddb8
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GKA | Abnormal Hemoglobin Quantitation | Hematology | 864.7415 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55876 | Multiple haemoglobin subtype IVD, kit, electrophoresis | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of multiple subtypes of haemoglobin in a clinical specimen, using an electrophoresis method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03607360025635 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232027 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- This Way Up_Fragile-handle with care_Keep Dry