AimScreen Fentanyl
- Primary DI
- 10695684423381
- Brand
- AimScreen Fentanyl
- Company
- GERMAINE LABORATORIES, INC
- Model
- 42338
- Published
- 2024-04-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| NGL | Test, Opiates, Over The Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00695684423384 | Primary | GS1 | 0 | |
| 10695684423381 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00695684423384 | 00695684423384 | 695684423384 | 0695684423384 |
| 10695684423381 | 10695684423381 |
GMDN Terms#
| Term | Definition |
|---|---|
| Fentanyl IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fentanyl in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 176458115
- Device count
- 25
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00695684744250 | AimStep Flu A&B Test Kit | 74425 | 2026-05-11 | |
| 00695684773014 | AimStrip Tandem Lipid Profile and glucose measuring system | ILM-0001A | 2020-03-13 | |
| 00695684775506 | AimStrip Tandem blood glucose test strips | ILM-0001A | 2020-03-13 | |
| 00695684773106 | AimStrip Tandem Total Cholesterol Test Strips | ILM-0001A | 2020-03-13 | |
| 00695684773120 | AimStrip Tandem Total Cholesterol Control Solution | ILM-0001A | 2020-03-13 | |
| 00695684774103 | AimStrip Tandem Total Triglycerides Test Strips | ILM-0001A | 2020-03-13 | |
| 00695684774127 | AimStrip Tandem Total Triglycerides Control Solution | ILM-0001A | 2020-03-13 | |
| 00695684775124 | AimStrip Tandem Glucose control solution | ILM-0001A | 2020-03-13 | |
| 00695684423384 | AimScreen Fentanyl | 42338 | 2024-04-01 | |
| 00695684893019 | Pregcolor Plus | 89301 | 2023-08-09 | |
| 00695684971014 | Pregcolor Premium | 97101PCP | 2023-08-09 | |
| 00695684957018 | Mosie Baby Pregnancy Test | 95701 | 2019-10-21 | |
| 00695684885304 | AIMSTRIP PREGNANCY | 88530 | 2016-04-11 | |
| 00695684888305 | AIMSTRIP COMBO PREGNANCY | 88830 | 2016-04-27 | |
| 00695684891015 | AccuHome Pregnancy Test | 89101 | 2016-04-11 | |
| 00695684891022 | AccuHome Pregnancy Test | 89102 | 2016-04-11 | |
| 00695684891404 | AccuHome Pregnancy Test | 89140 | 2016-04-11 | |
| 00695684970253 | AIMSTEP PREGNANCY | 97025 | 2016-04-11 | |
| 00695684970307 | AIMSTEP PREGNANCY | 97030 | 2016-04-11 | |
| 00695684970321 | AIMSTEP PREGNANCY | 97032 | 2016-06-18 |
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