FDA UDI
In Commercial Distribution
🇺🇸 United States
RAPID DIAGNOSTICS HCG TEST STRIP
DI: 00817830020265
·
Model: 07RD7001
·
RAPID DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RAPID DIAGNOSTICS HCG TEST STRIP
- Primary DI
- 00817830020265
- Version / Model
- 07RD7001
- Catalog Number
- 07RD7001
- Company Name
- RAPID DIAGNOSTICS INC
- Labeler DUNS
- 008028248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9d237c8a-f4b7-4543-86ba-c55de4caf735
Device Description
HCG TEST STRIP
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 |
|---|---|---|---|---|
| JHI | Visual, pregnancy hCG, prescription use | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54216 | Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817830020265 | GS1 |
Customer Contacts
- Phone
- +1(800)854-0530
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 72 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius