FDA UDI
In Commercial Distribution
🇺🇸 United States
Savanna
DI: 30014613340492
·
Model: M409-4
·
DIAGNOSTIC HYBRIDS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Savanna
- Primary DI
- 30014613340492
- Version / Model
- M409-4
- Catalog Number
- M409-4
- Company Name
- DIAGNOSTIC HYBRIDS, INC.
- Labeler DUNS
- 117359612
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-30
- Public Version
- 1
- Public Version Date
- 2024-05-08
- Public Version Status
- New
- Public Device Record Key
- 60634c2e-169c-4df2-aca8-9da2d9025dd2
Device Description
Savanna HSV 1+2/VZV Control Set
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
- 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 |
|---|---|---|---|---|
| PMN | Assayed external control material for microbiology nucleic acid amplification (NAT) assays | Microbiology | 866.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50411 | Multiple-type sexually transmitted pathogen nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30014613340492 | GS1 |
Customer Contacts
- Phone
- +1(858)552-1100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232286 | 000 |