FDA UDI
In Commercial Distribution
🇺🇸 United States
Gamma Lewis Blood Group Substance
DI: 10888234000853
·
Model: 0007702
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gamma Lewis Blood Group Substance
- Primary DI
- 10888234000853
- Version / Model
- 0007702
- Catalog Number
- 0007702
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3f8d156a-ffb8-468e-a8d9-c9155f68e5fb
Device Description
Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | Hematology | 864.9160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43805 | Immunoglobulin removal reagent IVD | A substance or reactant intended to be used alone or in combination with other IVDs for the removal, adsorption, absorption, or inactivation of non-specific immunoglobulins and/or rheumatoid factor antibodies present in a clinical specimen, to prevent interference when testing for other specific classes of immunoglobulin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234000853 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K802533 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 10 Degrees Celsius