FDA UDI
In Commercial Distribution
🇺🇸 United States
AIMSTRIP HEMOGLOBIN TEST COMBO
DI: 00695684782504
·
Model: 78250
·
GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- AIMSTRIP HEMOGLOBIN TEST COMBO
- Primary DI
- 00695684782504
- Version / Model
- 78250
- Company Name
- GERMAINE LABORATORIES, INC
- Labeler DUNS
- 176458115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-05-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- db60a9ee-8b94-4db7-91bc-94f7bfec6244
Device Description
For testing hemoglobin in whole blood
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KHG | Whole Blood Hemoglobin Determination | Hematology | 864.7500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57273 | Haemoglobin detection IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of haemoglobin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00695684782504 | GS1 | ||||
| Unit of Use | 00695684782505 | GS1 |