FDA UDI
In Commercial Distribution
🇺🇸 United States
Kallestad
DI: 00847865001649
·
Model: 26103
·
Bio-RAD Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kallestad
- Primary DI
- 00847865001649
- Version / Model
- 26103
- Catalog Number
- 26103
- Company Name
- Bio-RAD Laboratories, Inc.
- Labeler DUNS
- 844766394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 4
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- beb0f305-a270-4dff-81d9-213d4ad8581d
Device Description
Kallestad HEp-2 Cell Line 12 Well Slides
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | Immunology | 866.5090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54811 | Multiple antinuclear antibody (ANA) screening IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847865001649 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K810863 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12 Well | ||
| Device Size Text, specify | 240 Tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius