FDA UDI
In Commercial Distribution
🇺🇸 United States
N Latex IgE mono
DI: 00842768008078
·
Model: 10446129
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- N Latex IgE mono
- Primary DI
- 00842768008078
- Version / Model
- 10446129
- Catalog Number
- OQTG15
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- f595c9f3-d438-49b8-b99c-031efbb6aae7
Device Description
Quantitative determination of IgE in human serum and plasma on BN Systems
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61274 | Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using a nephelometry/turbidimetry method. It is typically used to screen for allergies associated with certain conditions (e.g., food intolerance). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768008078 | GS1 | ||||
| Unit of Use | 00842768018947 | GS1 |
Customer Contacts
- Phone
- +1(800)664-3822
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991787 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius