FDA UDI
In Commercial Distribution
🇺🇸 United States
NATtrol™
DI: 01220000260399
·
Model: NATtrol™ CT/NG/TV Negative Control
·
ZEPTOMETRIX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NATtrol™
- Primary DI
- 01220000260399
- Version / Model
- NATtrol™ CT/NG/TV Negative Control
- Catalog Number
- NATCTNGTV-NEG-IVD
- Company Name
- ZEPTOMETRIX CORPORATION
- Labeler DUNS
- 081586435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-08
- Public Version
- 1
- Public Version Date
- 2023-03-16
- Public Version Status
- New
- Public Device Record Key
- 9c19f17c-4ae2-4b9e-9825-cea9508bd1e5
Device Description
NATtrol™ CT/NG/TV Negative Control is a qualitative external run control intended to be used with molecular assays for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis DNA for the evaluation of test performance.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 862.1660 | 1 |
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 | 01220000260399 | GS1 |
Customer Contacts
- Phone
- 800-274-5487
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius