FDA UDI
In Commercial Distribution
🇺🇸 United States
NATtrol™
DI: 01220000260429
·
Model: NATtrol™ Vaginal Mini Bundle
·
ZEPTOMETRIX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NATtrol™
- Primary DI
- 01220000260429
- Version / Model
- NATtrol™ Vaginal Mini Bundle
- Catalog Number
- NATV-BU2
- Company Name
- ZEPTOMETRIX CORPORATION
- Labeler DUNS
- 081586435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-15
- Public Version
- 1
- Public Version Date
- 2023-12-25
- Public Version Status
- New
- Public Device Record Key
- 5edaa007-96e4-44a2-adc9-17e39e15c399
Device Description
NATtrol™ Vaginal Mini Bundle is a packaging configuration that contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) and NATtrol Vaginal Negative Control (NATVNEG-6C), 1 each, which are intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis 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 |
|---|---|---|---|---|
| 48210 | Multiple-type vaginitis-associated organism 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 organisms associated with vaginitis in a clinical specimen. Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 01220000260429 | GS1 |
Customer Contacts
- Phone
- 800-274-5487
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius