FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptima®
DI: 15420045505438
·
Model: KIT, BOX 2, RT, AGC 100-T, AS, IVD
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aptima®
- Primary DI
- 15420045505438
- Version / Model
- KIT, BOX 2, RT, AGC 100-T, AS, IVD
- Catalog Number
- 302943
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-16
- Public Version
- 4
- Public Version Date
- 2023-10-11
- Public Version Status
- Update
- Public Device Record Key
- 7c4bebad-8a07-40f5-a0f7-bd81f7c7c52c
Device Description
Aptima® GC assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Neisseria gonorrhoeae assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the Tigris® DTS® System or semi-automated instrumentation as specified.
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 |
|---|---|---|---|---|
| LSL | DNA-REAGENTS, NEISSERIA | Microbiology | 866.3390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51235 | Neisseria gonorrhoeae 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 Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea, in a clinical specimen using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045505438 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius