FDA UDI
In Commercial Distribution
🇺🇸 United States
APTIMA
DI: 15420045512894
·
Model: KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATED
·
Hologic, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- APTIMA
- Primary DI
- 15420045512894
- Version / Model
- KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATED
- Catalog Number
- PRD-05576
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-16
- Public Version
- 2
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 875ad554-8fc0-4549-b7d0-c38cbc6b1840
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| LSL | DNA-REAGENTS, NEISSERIA | Microbiology | 866.3390 | 2 |
| QEP | Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections | Microbiology | 866.3393 | 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 | 15420045512894 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius