FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCU NEWS Pregnancy Test Midstream
DI: 00850042559000
·
Model: Midstream
·
CORETESTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ACCU NEWS Pregnancy Test Midstream
- Primary DI
- 00850042559000
- Version / Model
- Midstream
- Company Name
- CORETESTS, INC.
- Labeler DUNS
- 036440919
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-31
- Public Version
- 2
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 442aeecd-ab84-47ea-8867-92579fc7bdf7
Device Description
3 pcs/box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10850042559007 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 00850042559000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150063 | 000 |