Immunalysis Corporation 3016-10

GUDID 00840937111949

Immunalysis Multi-Drug OF Control Set - Low and High Control

IMMUNALYSIS CORPORATION

Multiple clinical chemistry analyte IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control
Primary Device ID00840937111949
NIH Device Record Keyaefc47e3-eb93-4235-947a-70021ed03865
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunalysis Corporation
Version Model Number3016-10
Catalog Number3016-10
Company DUNS080589004
Company NameIMMUNALYSIS CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com
Phone909-482-0840
Emailinfo@immunalysis.com

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840937111949 [Primary]

FDA Product Code

DIFDrug Mixture Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-08
Device Publish Date2020-03-31

On-Brand Devices [Immunalysis Corporation]

00840937111673Immunalysis Corporation Meperidine Urine HEIA Kit 60 mL Wedge
00840937111666Immunalysis Corporation Meperidine Urine HEIA Kit 500
00840937111659Immunalysis Corporation Meperidine Urine HEIA Kit 100
00840937111642Immunalysis Corporation Meperidine Urine HEIA Kit 25
00840937105825Immunalysis Corporation Methylphenidate (Ritalin)
00840937104705Immunalysis Corporation Methylphenidate (Ritalin) Positive Control (5 mL)
00840937104699Immunalysis Corporation Methylphenidate (Ritalin) Positive Control (2 mL)
00840937108901Immunalysis Corporation - Multi-Drug Calibrator Level 1 (25mL)
00840937108895Immunalysis Corporation - Multi-Drug Calibrator Level 1 (15mL)
00840937108772Immunalysis Corporation - Fentanyl Urine Control Set
00840937111833Immunalysis Corporation - Quantisal Saliva Collection Devices - 500 Per Box
00840937111826Immunalysis Corporation - Quantisal Saliva Collection Devices - 25 Per Box
00840937111819Immunalysis Corporation - Tapentadol Urine Control Set
00840937111802Immunalysis Corporation - Tapentadol Urine Calibrator - 1000 ng/mL
00840937111796Immunalysis Corporation - Tapentadol Urine Calibrator - 300 ng/mL
00840937111789Immunalysis Corporation - Tapentadol Urine Calibrator - 200 ng/mL
00840937111772Immunalysis Corporation - Tapentadol Urine Calibrator - 100 ng/mL
00840937111765Immunalysis Corporation - Tapentadol Urine HEIA Wedge Kit 60
00840937111758Immunalysis Corporation - Tapentadol Urine HEIA Kit 500
00840937111741Immunalysis Corporation - Tapentadol Urine HEIA Kit 100
00840937111734Immunalysis Corporation - Tapentadol Urine HEIA Kit 25
00840937111635Immunalysis Corporation Benzodiazepines Oral Fluid Export Kit 500
00840937111628Immunalysis Corporation Benzodiazepines Oral Fluid Export Kit 100
00840937111611Immunalysis Corporation Benzodiazepines Oral Fluid Export Kit 25
00840937111604Immunalysis Corporation Negative Reference Calibrator
00840937111598Immunalysis Corporation Tramadol Urine HEIA Kit 25
00840937111581Immunalysis Corporation Tramadol Urine Control Set
00840937111574Immunalysis Corporation Tramadol Urine Calibrator Set
00840937111567Immunalysis Corporation Tramadol Urine Calibrator
00840937111550Immunalysis Corporation Oxycodone Urine HEIA 25
00840937111543Immunalysis Corporation Oxycodone Urine Control Set 300
00840937111536Immunalysis Corporation Oxycodone Urine Control Set 100
00840937111529Immunalysis Corporation Oxycodone Urine Calibrator Set
00840937111512Immunalysis Corporation Oxycodone Urine Calibrator 300
00840937111505Immunalysis Corporation Oxycodone Urine Calibrator 100
00840937111499Immunalysis Corporation Negative Calibrator
00840937111482Immunalysis Corporation SEFRIA Fentanyl Urine Kit 25
00840937111475Immunalysis Corporation Fentanyl Urine Control Set
00840937111468Immunalysis Corporation Fentanyl Urine Calibrator Level 1 - 1 ng/mL
00840937111451Immunalysis Corporation EDDP Specific Urine HEIA 25 Kit
00840937111444Immunalysis Corporation EDDP Specific Urine Control Set Level 2
00840937111437Immunalysis Corporation EDDP Specific Urine Control Set Level 1
00840937111420Immunalysis Corporation EDDP Specific Urine Calibrator Level 4 - 1000 ng/mL
00840937111413Immunalysis Corporation EDDP Specific Urine Calibrator Level 3 - 500 ng/mL
00840937111406Immunalysis Corporation EDDP Specific Urine Calibrator Level 2 - 300 ng/mL
00840937111390Immunalysis Corporation EDDP Specific Urine Calibrator Level 1 - 100 ng/ml
00840937111383Immunalysis Corporation Buprenorphine Urine HEIA Kit 25
00840937111376Immunalysis Corporation Buprenorphine Urine Control Set
00840937111369Immunalysis Corporation Buprenorphine Urine Calibrator Set
00840937111352Immunalysis Corporation Buprenorphine Urine Calibrator

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