FDA UDI In Commercial Distribution 🇺🇸 United States

ALKALINE PHOSPHATASE

DI: 00852223007140 · Model: 2115-0 · STERLING DIAGNOSTICS INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ALKALINE PHOSPHATASE
Primary DI
00852223007140
Version / Model
2115-0
Catalog Number
2115-0
Company Name
STERLING DIAGNOSTICS INC
Labeler DUNS
155284151
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-14
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
335a0817-381f-4b3c-b430-bbe2718ed7c4

Device Description

ALKALINE PHOSPHATASE (COLORIMETRIC TMP)

Device Characteristics

Single Use
No
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
52931 Alkaline phosphatase (ALP) isoenzyme IVD, reagent

Identifiers

Type ID
Primary 00852223007140