FDA UDI Not in Commercial Distribution 🇺🇸 United States

Cal-Lyse™ Lysing Solution 1000 Tests

DI: 10190302008884 · Model: GAS010S100 · LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Cal-Lyse™ Lysing Solution 1000 Tests
Primary DI
10190302008884
Version / Model
GAS010S100
Company Name
LIFE TECHNOLOGIES CORPORATION
Labeler DUNS
080131636
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-02-02
Public Version
4
Public Version Date
2022-06-03
Public Version Status
Update
Public Device Record Key
2c69f415-5213-40b0-b078-3397d161f9f4
Distribution End Date
2022-05-31

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
GGK PRODUCTS, RED-CELL LYSING PRODUCTS

GMDN Terms

Code Name
61165 Blood cell lysis reagent IVD

Identifiers

Type ID
Primary 10190302008884