FDA UDI
In Commercial Distribution
🇺🇸 United States
GammaZyme-B
DI: 10888234000716
·
Model: 0007058
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GammaZyme-B
- Primary DI
- 10888234000716
- Version / Model
- 0007058
- Catalog Number
- 0007058
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9d5f0920-74a5-4b75-9b85-8752715c8602
Device Description
GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration.
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 |
|---|---|---|---|---|
| KSK | Solution, Stabilized Enzyme | Hematology | 864.9400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52709 | Bromelin immunohaematology reagent IVD | A substance or reactant that is a bromelin enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234000716 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK880016 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 10 Degrees Celsius