FDA UDI
In Commercial Distribution
🇺🇸 United States
KWIK-STIK™
DI: 10845357020175
·
Model: 0828U
·
MICROBIOLOGICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- KWIK-STIK™
- Primary DI
- 10845357020175
- Version / Model
- 0828U
- Catalog Number
- 0828U
- Company Name
- MICROBIOLOGICS INC.
- Labeler DUNS
- 060467826
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 2
- Public Version Date
- 2025-11-21
- Public Version Status
- Update
- Public Device Record Key
- a7284955-801a-4bfe-8111-66423518fbe3
Device Description
KWIK-STIK™ P. bifermentans ATCC 638™
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| JTR | KIT, QUALITY CONTROL FOR CULTURE MEDIA | Microbiology | 866.2480 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61331 | Multiple bacteria species culture isolate identification control IVD, kit | A collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species 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 | 20845357020172 | GS1 | 2 Pack | 2 | In Commercial Distribution | |
| Primary | 10845357020175 | GS1 | ||||
| Package | 30845357020186 | GS1 | 6 Pack | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(320)253-7400
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius