Mast Cell Tryptase [AA1]

GUDID 00847627030757

BIOCARE MEDICAL LLC

Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell tryptase IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody Mast cell protease IVD, antibody
Primary Device ID00847627030757
NIH Device Record Keyfa8a23bb-e2b0-472e-8b35-d03817e6dfc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMast Cell Tryptase [AA1]
Version Model NumberACI3277A
Company DUNS806617825
Company NameBIOCARE MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627030757 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

On-Brand Devices [Mast Cell Tryptase [AA1]]

00847627030801AVI3277G
00847627030795ALI3277G7
00847627030788OPAI3277T60
00847627030771API3277AA
00847627030764ACI3277C
00847627030757ACI3277A

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.