FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479269880
·
Model: RSV001
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
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Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479269880
- Version / Model
- RSV001
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-09-09
- Public Version
- 2
- Public Version Date
- 2025-11-24
- Public Version Status
- Update
- Public Device Record Key
- 21dccb67-bbdf-4327-8303-83448396f4a5
Device Description
RSV Antigen Test (12/kt, 48kt/cs)
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
- 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
- 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 |
|---|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Microbiology | 866.3480 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49505 | Respiratory syncytial virus (RSV) antigen IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from respiratory syncytial virus (RSV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612479269897 | GS1 | Case | 48 | In Commercial Distribution | |
| Primary | 00612479269880 | GS1 | ||||
| Unit of Use | 00612479269873 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021789 | 000 |