FDA UDI
In Commercial Distribution
🇺🇸 United States
hemochroma PLUS Microcuvettes
DI: 10722355003020
·
Model: 100-202
·
IMMUNOSTICS COMPANY, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- hemochroma PLUS Microcuvettes
- Primary DI
- 10722355003020
- Version / Model
- 100-202
- Catalog Number
- 100-202
- Company Name
- IMMUNOSTICS COMPANY, INC
- Labeler DUNS
- 119214195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2018-12-20
- Public Version
- 1
- Public Version Date
- 2019-01-21
- Public Version Status
- New
- Public Device Record Key
- c7d09436-71b1-48c4-a756-adcd2bb44f03
Device Description
The hemochroma PLUS Microcuvettes are used for measurement of hemoglobin concentration in human whole blood along with the hemochroma PLUS Analyzer. The hemochroma PLUS Microcuvette is inserted into a holder of hemochroma PLUS Analyzer for quantification of hemoglobin in blood
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
- 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 |
|---|---|---|---|---|
| GKR | SYSTEM, HEMOGLOBIN, AUTOMATED | Hematology | 864.5620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55875 | Total haemoglobin (totHb) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10722355003020 | GS1 | ||||
| Unit of Use | 80722355003029 | GS1 |
Customer Contacts
- Phone
- +1(732)918-0770
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius