FDA UDI
In Commercial Distribution
🇺🇸 United States
APTIMA
DI: 15420045514966
·
Model: AC2, ROOM TEMP, 250T, READY MADE
·
Hologic, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- APTIMA
- Primary DI
- 15420045514966
- Version / Model
- AC2, ROOM TEMP, 250T, READY MADE
- Catalog Number
- PRD-07039
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-28
- Public Version
- 2
- Public Version Date
- 2024-10-14
- Public Version Status
- Update
- Public Device Record Key
- 42a22c29-764b-438b-911a-d291b90b8d7a
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 |
|---|---|---|---|---|
| QEP | Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections | Microbiology | 866.3393 | 2 |
| LSL | DNA-REAGENTS, NEISSERIA | Microbiology | 866.3390 | 2 |
| MKZ | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | Microbiology | 866.3120 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50409 | Multiple-type sexually transmitted 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 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 | 15420045514966 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200436 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius