FDA UDI
Not in Commercial Distribution
🇺🇸 United States
L-Type HDL-C (Reagent 2)
DI: 10856626006141
·
Model: 997-00201
·
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- L-Type HDL-C (Reagent 2)
- Primary DI
- 10856626006141
- Version / Model
- 997-00201
- Catalog Number
- 997-00201
- Company Name
- FUJIFILM WAKO PURE CHEMICAL CORPORATION
- Labeler DUNS
- 690598875
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-11-11
- Public Version
- 6
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- 299f709a-e933-4b4d-b278-9a16b0c1e7da
- Distribution End Date
- 2020-10-23
Device Description
The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in serum. (4 each 600 mL)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JIS | Calibrator, Primary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44696 | High density lipoprotein (HDL) cholesterol IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10856626006141 | GS1 | ||||
| Unit of Use | 00856626006144 | GS1 |
Customer Contacts
- Phone
- 877-714-1924
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963847 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at 2-10C. Do not freeze.