FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica CH AlbP
DI: 00630414595825
·
Model: 11097530
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Atellica CH AlbP
- Primary DI
- 00630414595825
- Version / Model
- 11097530
- Catalog Number
- 11097530
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2017-12-22
- Public Version
- 6
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- bb6dfbd1-8149-4095-b050-e4ad2efa7e74
Device Description
Albumin BCP (AlbP) Atellica CH - RGT 6400T
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 |
|---|---|---|---|---|
| CJW | BROMCRESOL PURPLE DYE-BINDING, ALBUMIN | Clinical Chemistry | 862.1035 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59071 | Albumin IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a spectrophotometry method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414595825 | GS1 | ||||
| Unit of Use | 00630414006871 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151767 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius