FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 00722066003244
·
Model: HCG-3S100
·
BTNX Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 00722066003244
- Version / Model
- HCG-3S100
- Catalog Number
- HCG-3S100
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 5
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5ca1e60d-eacd-44a9-97d6-bd7a5a1fe906
Device Description
Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qualitative detection of Human Chorionic Gonadotropin in urine/ serum.
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 |
|---|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33819 | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)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 within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00722066003244 | GS1 | ||||
| Unit of Use | 00722066004227 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132834 | 000 |