FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 10722066005146
·
Model: HCG-1C50
·
BTNX Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 10722066005146
- Version / Model
- HCG-1C50
- Catalog Number
- HCG-1C50
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-08-14
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7b78da68-655d-4c85-a984-f13d93ff0384
- Distribution End Date
- 2023-04-27
Device Description
Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54210 | Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen using an enzyme immunoassay (EIA) method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10722066005146 | GS1 | ||||
| Unit of Use | 00722066005149 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122907 | 000 |