MTS MTS081001

GUDID 10758750005949

MTS Monoclonal Control Card

MICRO TYPING SYSTEMS, INC

Antisera matrix (non-reactive) IVD, control
Primary Device ID10758750005949
NIH Device Record Key85f2665b-a956-4ca7-840c-369f4eaff42c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTS
Version Model NumberMTS081001
Catalog NumberMTS081001
Company DUNS781421888
Company NameMICRO TYPING SYSTEMS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110758750005949 [Primary]

FDA Product Code

KSFKIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-21
Device Publish Date2016-08-24

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10758750006045MTS Diluent 2 Plus
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10758750006106MTS™ Worktable (plastic rack to hold cards and samples)
10758750006090ID-TIPMASTER
10758750006069MTS DISPENSER 1.0ML
10758750006052MTS DISPENSER 0.5ML
10758750006007MTS Buffered Gel Card
10758750005949MTS Monoclonal Control Card
10758750006113MTS™ Incubator
10758750005802MTS™ Centrifuge model 5150-60

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