FDA UDI In Commercial Distribution 🇺🇸 United States

AccuSign® MET 500 card

DI: 10743816000075 · Model: DOA-202E-35-00 · PRINCETON BIOMEDITECH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AccuSign® MET 500 card
Primary DI
10743816000075
Version / Model
DOA-202E-35-00
Catalog Number
DOA-202E-35-00
Company Name
PRINCETON BIOMEDITECH CORPORATION
Labeler DUNS
362917692
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
3
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
a8d6b393-2ec2-4ca0-b718-4314fbb1dec3

Device Description

AccuSign® MET 500 card; 35 Test kit

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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DJC Thin Layer Chromatography, Methamphetamine

GMDN Terms

Code Name
55498 Methamphetamine-specific IVD, kit, rapid ICT, clinical

Identifiers

Type ID
Primary 10743816000075

Customer Contacts

Phone
7322741000

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 30 Degrees Celsius