FDA UDI
Not in Commercial Distribution
🇺🇸 United States
STEROID-SKREEN
DI: 00810042681941
·
Model: 35061843
·
BIOCHEMICAL DIAGNOSTICS INC
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STEROID-SKREEN
- Primary DI
- 00810042681941
- Version / Model
- 35061843
- Catalog Number
- 35061843
- Company Name
- BIOCHEMICAL DIAGNOSTICS INC
- Labeler DUNS
- 028007698
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 2
- Public Version Date
- 2022-01-11
- Public Version Status
- Update
- Public Device Record Key
- 1f8aa286-c011-4bb8-942a-5c698bf0b874
- Distribution End Date
- 2022-01-10
Device Description
POTASSIUM HYDROXIDE, 7N, 2.0L
Device Characteristics
- Single Use
- No
- 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
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCY | Zimmerman (Spectrophotometric), 17-Ketosteroids | Clinical Chemistry | 862.1430 | 1 |
| CCZ | Zimmerman/Norymberski, 17-Ketogenic Steroids | Clinical Chemistry | 862.1385 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54050 | 17-Ketosteroid (17KS) 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 detection of 17-ketosteroids (17KS) in a clinical specimen. | No | Active |
| 54047 | 17-Ketogenic steroid (17KGS) 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 detection of 17-ketogenic steroids (17KGS) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810042681941 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius