FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptima®
DI: 15420045517073
·
Model: KIT, BOX 1, REFRIGERATED, ACV/TV, 250T, IVD
·
Hologic, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aptima®
- Primary DI
- 15420045517073
- Version / Model
- KIT, BOX 1, REFRIGERATED, ACV/TV, 250T, IVD
- Catalog Number
- ASY-16708
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-19
- Public Version
- 2
- Public Version Date
- 2025-05-09
- Public Version Status
- Update
- Public Device Record Key
- 28e93d64-004e-46bd-9e8f-a621b07a3a9d
Device Description
Aptima® CV/TV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NSU | Instrumentation for clinical multiplex test systems | Clinical Chemistry | 862.2570 | 2 |
| PQA | Vaginitis and bacterial vaginosis nucleic acid detection system | Microbiology | 866.3975 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48208 | Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of pathogens associated with vaginitis and/or vaginosis in a clinical specimen, using a nucleic acid technique (NAT). Pathogens 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 | 15420045517073 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243345 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius