FDA UDI
In Commercial Distribution
🇺🇸 United States
3-Reagent Homocysteine Assay for SYNCHRON UniCel
DI: 05055845400084
·
Model: FHYB100/B08175
·
AXIS-SHIELD DIAGNOSTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 3-Reagent Homocysteine Assay for SYNCHRON UniCel
- Primary DI
- 05055845400084
- Version / Model
- FHYB100/B08175
- Catalog Number
- FHYB100/B08175
- Company Name
- AXIS-SHIELD DIAGNOSTICS LIMITED
- Labeler DUNS
- 229062427
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-01
- Public Version
- 5
- Public Version Date
- 2025-05-30
- Public Version Status
- Update
- Public Device Record Key
- 1bde5089-8078-4b71-ac31-a1fd040ef599
Device Description
The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LPS | Urinary Homocystine (Nonquantitative) Test System | Clinical Chemistry | 862.1377 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53751 | Homocysteine IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055845400084 | GS1 |
Customer Contacts
- Phone
- +441382422000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112790 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius