FDA UDI
In Commercial Distribution
🇺🇸 United States
RET-SEARCH II
DI: 00664369201340
·
Model: RED-700A
·
SYSMEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RET-SEARCH II
- Primary DI
- 00664369201340
- Version / Model
- RED-700A
- Company Name
- SYSMEX CORPORATION
- Labeler DUNS
- 690664461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-04
- Public Version
- 1
- Public Version Date
- 2022-11-14
- Public Version Status
- New
- Public Device Record Key
- a95d545e-40d1-4563-991b-a242f5c5ed1e
Device Description
Diluent and dye for reticulocyte count with hematology analyzers. Reticulocyte test kit for determination of reticulocyte count and reticulocyte percent in human blood. Contents: RET-SEARCH (II) Diluent (RED-300) and RET-SEARCH (II) Dye (RED-800)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| GIF | Diluent, Blood Cell | Hematology | 864.8200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55862 | Reticulocyte count IVD, kit, cell count | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen using a manual, semi-automated or automated cell count method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00664369201340 | GS1 |
Customer Contacts
- Phone
- +1(888)879-7639
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1000 | Milliliter | |
| Total Volume | 12 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT FREEZE
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 35 Degrees Celsius