FDA UDI
Not in Commercial Distribution
🇺🇸 United States
STEROID-SKREEN
DI: 00810042681705
·
Model: 35060162
·
BIOCHEMICAL DIAGNOSTICS INC
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STEROID-SKREEN
- Primary DI
- 00810042681705
- Version / Model
- 35060162
- Catalog Number
- 35060162
- Company Name
- BIOCHEMICAL DIAGNOSTICS INC
- Labeler DUNS
- 028007698
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-30
- Public Version
- 2
- Public Version Date
- 2022-01-11
- Public Version Status
- Update
- Public Device Record Key
- a4f105cb-fe1d-47e5-be15-146bf84f3694
- Distribution End Date
- 2022-01-10
Device Description
CLINI-SKREEN COLUMNS 500PK
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CDB | Porter Silber Hydrazone, 17-Hydroxycorticosteroids | Clinical Chemistry | 862.1385 | 1 |
| CCY | Zimmerman (Spectrophotometric), 17-Ketosteroids | Clinical Chemistry | 862.1430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45762 | 17-Ketosteroid (17KS) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of 17-ketosteroids (17KS) in a clinical specimen. | No | Active |
| 54032 | 17-Hydroxycorticoid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of 17-hydroxycorticoids in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810042681705 | GS1 |
Customer Contacts
- Phone
- 631-595-9200
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius