Mission Urinalysis Reagent Strips

GUDID 20682607200140

Mission Urinalysis Reagent Strips (BLO/LEU)

ACON LABORATORIES, INC.

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Primary Device ID20682607200140
NIH Device Record Key31fed4db-a28d-4aff-9dca-be84265865c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMission Urinalysis Reagent Strips
Version Model NumberU031-021
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607000777 [Unit of Use]
GS100682607200146 [Primary]
GS120682607200140 [Package]
Contains: 00682607200146
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIOBLOOD, OCCULT, COLORIMETRIC, IN URINE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-22
Device Publish Date2016-09-24

On-Brand Devices [Mission Urinalysis Reagent Strips]

20682607200416Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
20682607200409Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
20682607200393Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT)
20682607200386Mission Urinalysis Reagent Strips (PH/GLU/BIL/PRO/URO/NIT/LEU/KET)
20682607200379Mission Urinalysis Reagent Strips (GLU/SG/BLO/PH/PRO/URO/NIT/LEU)
20682607200362Mission Urinalysis Reagent Strips (GLU/KET/SG/BLO/PH/PRO/NIT/LEU)
20682607200355Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT)
20682607200348Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)
20682607200331Mission Urinalysis Reagent Strips (BIL/SG/BLO/URO/PRO/NIT)
20682607200324Mission Urinalysis Reagent Strips (GLU/PRO/PH/BLO/NIT/LEU)
20682607200317Mission Urinalysis Reagent Strip (BIL/URO/LEU/NIT/BLO)
20682607200300Mission Urinalysis Reagent Strip (GLU/SG/PRO/PH/BLO)
20682607200294Mission Urinalysis Reagent Strips (GLU/PRO/NIT/BLO/LEU)
20682607200287Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH/BLO)
20682607200270Mission Urinalysis Reagent Strips (PRO/NIT/BLO/LEU)
20682607200263Mission Urinalysis Reagent Strip (PRO/GLU/LEU/BLO)
20682607200256Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH)
20682607200249Mission Urinalysis Reagent Strip (GLU/PRO/PH/BLO)
20682607200232Mission Urinalysis Reagent Strip (GLU/SG/PH/PRO)
20682607200225Mission Urinalysis Reagent Strip (GLU/PRO/NIT/LEU)
20682607200218Mission Urinalysis Reagent Strip (BLO/NIT/LEU)
20682607200201Mission Urinalysis Reagent Strips (GLU/KET/PH)
20682607200195Mission Urinalysis Reagent Strips (GLU/KET/PRO)
20682607200188Mission Urinalysis Reagent Strips (GLU/PH/PRO)
20682607200171Mission Urinalysis Reagent Strips (ALB/CRE)
20682607200164Mission Urinalysis Reagent Strips (SG/PH)
20682607200157Mission Urinalysis Reagent Strips (BIL/URO)
20682607200140Mission Urinalysis Reagent Strips (BLO/LEU)
20682607200133Mission Urinalysis Reagent Strips (NIT/LEU)
20682607200126Mission Urinalysis Reagent Strips (GLU/KET)
20682607200119Mission Urinalysis Reagent Strips (GLU/PRO)
20682607200102Mission Urinalysis Reagent Strips (PRO)
20682607200096Mission Urinalysis Reagent Strips (KET)
20682607200089Mission Urinalysis Reagent Strips (GLU)
20682607200072Mission Urinalysis Reagent Strips (PH)
20682607200065Mission Urinalysis Reagent Strips (BLO)
00682607000685Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
00682607000678Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
00682607000661Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT)
00682607000654Mission Urinalysis Reagent Strips (PH/GLU/BIL/PRO/URO/NIT/LEU/KET)
00682607000647Mission Urinalysis Reagent Strips (GLU/SG/BLO/PH/PRO/URO/NIT/LEU)
00682607000630Mission Urinalysis Reagent Strips (GLU/KET/SG/BLO/PH/PRO/NIT/LEU)
00682607000623Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT)
00682607000616Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)
00682607000609Mission Urinalysis Reagent Strips (BIL/SG/BLO/URO/PRO/NIT)
00682607000593Mission Urinalysis Reagent Strips (GLU/PRO/PH/BLO/NIT/LEU)
00682607000586Mission Urinalysis Reagent Strip (BIL/URO/LEU/NIT/BLO)
00682607000579Mission Urinalysis Reagent Strip (GLU/SG/PRO/PH/BLO)
00682607000562Mission Urinalysis Reagent Strips (GLU/PRO/NIT/BLO/LEU)
00682607000555Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH/BLO)

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