FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMUNO CONCEPTS Test Systems
DI: M7491012201
·
Model: 1012 (20)
·
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 Test Systems
- Primary DI
- M7491012201
- Version / Model
- 1012 (20)
- Catalog Number
- 1012 (20)
- 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
- 4
- Public Version Date
- 2025-06-03
- Public Version Status
- Update
- Public Device Record Key
- 879b6ae4-9455-454b-93d2-8639f5db5b4d
Device Description
Universal PBS Buffer Powder - 20 x 1 Pkg.
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 |
|---|---|---|---|---|
| 42693 | pH-adjusted buffer solution IVD | A pH-adjusted buffer solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7491012201 | HIBCC |