FDA UDI
In Commercial Distribution
🇺🇸 United States
EliA IgM Conjugate 50
DI: 07333066012964
·
Model: 83-0006-11
·
Phadia AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EliA IgM Conjugate 50
- Primary DI
- 07333066012964
- Version / Model
- 83-0006-11
- Catalog Number
- 83-0006-11
- Company Name
- Phadia AB
- Labeler DUNS
- 354019424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f1b63aea-b712-49cc-b3da-dd3721e9022c
Device Description
EliA IgM 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 |
|---|---|---|---|---|
| 53792 | Total immunoglobulin M (IgM 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 M (IgM 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 | 07333066013954 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 07333066012964 | GS1 |
Customer Contacts
- Phone
- +469999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091845 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze!