FDA UDI
In Commercial Distribution
🇺🇸 United States
VITROS
DI: 10758750034291
·
Model: 6199334
·
ORTHO CLINICAL DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VITROS
- Primary DI
- 10758750034291
- Version / Model
- 6199334
- Catalog Number
- 6199334
- Company Name
- ORTHO CLINICAL DIAGNOSTICS
- Labeler DUNS
- 215865786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-18
- Public Version
- 2
- Public Version Date
- 2025-02-19
- Public Version Status
- Update
- Public Device Record Key
- 929495ec-25a6-43ae-90cd-1adcf9be0ee9
Device Description
VITROS Immunodiagnostic Products Total B HCG II Reagent Pack
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54211 | Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay | 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 a chemiluminescent immunoassay 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 |
|---|---|---|---|---|---|---|
| Package | 20758750034298 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 10758750034291 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233581 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze