FDA UDI
Not in Commercial Distribution
🇺🇸 United States
API® 20 E Reagent QC
DI: 03573026588410
·
Model: API® 20 E Reagent QC
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- API® 20 E Reagent QC
- Primary DI
- 03573026588410
- Version / Model
- API® 20 E Reagent QC
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2020-04-10
- Public Version
- 2
- Public Version Date
- 2021-10-28
- Public Version Status
- Update
- Public Device Record Key
- f0a63600-6178-4bed-b1ae-f97199123756
- Distribution End Date
- 2021-10-05
Device Description
API 20 E Reagent QC test kit is a abbreviated version of API 20 E strip containing substrates for tryptophane deaminase, indole, nitrate reduction and Voges-Proskauer tests
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
- Yes
- 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 |
|---|---|---|---|---|
| JSS | KIT, IDENTIFICATION, ENTEROBACTERIACEAE | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50417 | Multiple gram negative bacteria species culture isolate identification IVD, kit | A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of gram negative bacteria belonging to the Enterobacteriaceae or non-Enterobacteriaceae families, that have been isolated by culture from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03573026048136 | GS1 | 1 | Not in Commercial Distribution | 2021-10-05 | |
| Primary | 03573026588410 | GS1 | ||||
| Unit of Use | 03573026588427 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius