FDA UDI
In Commercial Distribution
🇺🇸 United States
FastPack® IP SHBG
DI: 20816467020345
·
Model: FastPack® IP SHBG 30 Immunoassay
·
QUALIGEN INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- FastPack® IP SHBG
- Primary DI
- 20816467020345
- Version / Model
- FastPack® IP SHBG 30 Immunoassay
- Catalog Number
- 25000081
- Company Name
- QUALIGEN INC.
- Labeler DUNS
- 959103565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2019-03-15
- Public Version
- 1
- Public Version Date
- 2019-03-25
- Public Version Status
- New
- Public Device Record Key
- cf2e7782-8108-48fa-9c05-461197bd4732
Device Description
30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | Clinical Chemistry | 862.1680 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54360 | Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of sex hormone binding globulin (SHBG) in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20816467020345 | GS1 | ||||
| Unit of Use | 00816467020341 | GS1 |
Customer Contacts
- Phone
- 1-877-770-6127
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182521 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius