FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoCAP Total IgE Calibrator Strip
DI: 07333066019796
·
Model: 34-2274-81
·
Phadia AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ImmunoCAP Total IgE Calibrator Strip
- Primary DI
- 07333066019796
- Version / Model
- 34-2274-81
- Catalog Number
- 34-2274-81
- Company Name
- Phadia AB
- Labeler DUNS
- 354019424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-28
- Public Version
- 1
- Public Version Date
- 2019-04-05
- Public Version Status
- New
- Public Device Record Key
- b47d0140-67a6-43bf-bcf3-0227e7eb7213
Device Description
ImmunoCAP Total IgE Calibrator Strip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53776 | Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333066000367 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 07333066019796 | GS1 |
Customer Contacts
- Phone
- +469999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133404 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius