FDA UDI In Commercial Distribution 🇺🇸 United States

FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml

DI: 00812117016207 · Model: N/A · ONE LAMBDA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml
Primary DI
00812117016207
Version / Model
N/A
Catalog Number
FQAE2000
Company Name
ONE LAMBDA, INC.
Labeler DUNS
118289289
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-05-31
Public Version
1
Public Version Date
2018-07-02
Public Version Status
New
Public Device Record Key
514b8430-5292-4a9a-b5bf-12271e4df997

Device Description

FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KQC Stains, Hematology

GMDN Terms

Code Name
15599 Microscope slide stainer IVD

Identifiers

Type ID
Primary 00812117016207

Customer Contacts

Phone
800.822.8824

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 5 Degrees Celsius