FDA UDI
In Commercial Distribution
🇺🇸 United States
D3 Fastpoint
DI: 30014613330851
·
Model: 01-123104
·
DIAGNOSTIC HYBRIDS, INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- D3 Fastpoint
- Primary DI
- 30014613330851
- Version / Model
- 01-123104
- Catalog Number
- 01-123104
- Company Name
- DIAGNOSTIC HYBRIDS, INC.
- Labeler DUNS
- 117359612
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-07
- Public Version
- 2
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- 8523cff2-06e8-463d-b483-694a19b3ff41
Device Description
L-DFA Influenza A/Influenza B Reagent
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 |
|---|---|---|---|---|
| LKT | RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA | Microbiology | 866.3480 | 1 |
| GNY | ANTISERA, FLUORESCENT, ADENOVIRUS 1-33 | Microbiology | 866.3020 | 1 |
| GQS | ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4 | Microbiology | 866.3400 | 1 |
| GNS | ANTISERA, HAI, INFLUENZA VIRUS A, B, C | Microbiology | 866.3330 | 1 |
| OMG | Antisera, fluorescent, human metapneumovirus | Microbiology | 866.3980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49117 | Influenza A/B virus antigen IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30014613330851 | GS1 |
Customer Contacts
- Phone
- +1(858)552-1100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091171 | 000 |