FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMUNO CONCEPTS Substrate Slide Test Systems
DI: M7490104211
·
Model: 1042 (1)
·
IMMUNO CONCEPTS INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IMMUNO CONCEPTS Substrate Slide Test Systems
- Primary DI
- M7490104211
- Version / Model
- 1042 (1)
- Catalog Number
- 1042 (1)
- Company Name
- IMMUNO CONCEPTS INC
- Labeler DUNS
- 038271904
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2025-06-03
- Public Version Status
- Update
- Public Device Record Key
- 178481b0-eb87-44a9-8f1e-dde9427f11f2
Device Description
Coverslips 24 x 64mm - 1 oz
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15687 | Microscope slide coverslip IVD | A thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7490104211 | HIBCC |