FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemoglobin Total Linearity Control
DI: 00817869020175
·
Model: HC-110LIN
·
ANALYTICAL CONTROL SYSTEMS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Hemoglobin Total Linearity Control
- Primary DI
- 00817869020175
- Version / Model
- HC-110LIN
- Catalog Number
- HC-110LIN
- Company Name
- ANALYTICAL CONTROL SYSTEMS INC
- Labeler DUNS
- 038232682
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-31
- Public Version
- 1
- Public Version Date
- 2019-03-04
- Public Version Status
- New
- Public Device Record Key
- 497626f2-050f-425a-8ab8-d87b17e564ef
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KHG | Whole Blood Hemoglobin Determination | Hematology | 864.7500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59803 | Inherited haemoglobinopathy IVD, control | A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817869020175 | GS1 | ||||
| Package | 10817869020172 | GS1 | 6 pack | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K802568 | 000 |