FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit
DI: 10816068020211
·
Model: 111011
·
ADVANCED INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit
- Primary DI
- 10816068020211
- Version / Model
- 111011
- Catalog Number
- 111011
- Company Name
- ADVANCED INSTRUMENTS, INC.
- Labeler DUNS
- 125006353
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6a273521-b0c5-4492-96ca-f30f451f1419
Device Description
For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Red Blood Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Red Blood Cell (RBC) Reagent.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | Hematology | 864.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52740 | Red cell antibody eluting IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in the process of eluting antibodies bound to antigens present on the surface of red blood cells of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10816068020211 | GS1 | ||||
| Unit of Use | 00816068020214 | GS1 |
Customer Contacts
- Phone
- +17813209000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152776 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius