FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoCAP Specific IgG Conjugate 50
DI: 07333066019765
·
Model: 34-2271-71
·
Phadia AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoCAP Specific IgG Conjugate 50
- Primary DI
- 07333066019765
- Version / Model
- 34-2271-71
- Catalog Number
- 34-2271-71
- 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
- 80c08ceb-b02d-4868-925c-263ba3756047
Device Description
ImmunoCAP Specific IgG Conjugate 50
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| JJY | Multi-analyte controls, all kinds (assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53783 | Total immunoglobulin G (IgG 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 G (IgG 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 | 07333066000770 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 07333066019765 | GS1 | ||||
| Package | 07333066000190 | GS1 | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +469999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072661 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze!
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius