FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Diff-Quik™ Fixative
DI: 00630414992624
·
Model: 10459379
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diff-Quik™ Fixative
- Primary DI
- 00630414992624
- Version / Model
- 10459379
- Catalog Number
- B4132-10A
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 4
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 94dc59e5-a7b7-4344-b840-a9cbece2ba4f
- Distribution End Date
- 2018-09-25
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
- Yes
- 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 |
|---|---|---|---|---|
| KQC | STAINS, HEMATOLOGY | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43606 | Differentiation solution IVD | A differentiation solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414992624 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius