FDA UDI
In Commercial Distribution
🇺🇸 United States
ZEUS Wash Solution
DI: 00845533001786
·
Model: 0103
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZEUS Wash Solution
- Primary DI
- 00845533001786
- Version / Model
- 0103
- Catalog Number
- 0103
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a9caa4d9-f7d1-4da1-8530-34290a56def6
Device Description
The ZEUS Tissue Fixative and Wash Solution is intended for transporting and processing fresh skin, kidney tissue, muscle, and benign or malignant lymphoid tissue when performing immunohistochemical examinations, and is for In Vitro diagnostic use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57749 | Michel’s solution IVD | A solution typically containing an anti-autolytic agent and ammonium sulfate intended to be used as a fixative in the processing of biological tissues and clinical specimens. Michel?s solution is generally used for fixation of tissue-bound immunoglobulins and aids in the diagnosis of certain skin diseases including pemphigus, dermatitis herpetiformis, and kidney diseases such as glomerulonephritis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533001786 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius