Immunalysis Corporation

GUDID 00840937100400

Immunalysis Corporation Meperidine (Demerol/Pethidine) Direct ELISA Kit: 1 plate

IMMUNALYSIS CORPORATION

Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent Opiate/opiate metabolite IVD, reagent
Primary Device ID00840937100400
NIH Device Record Key8747bfc2-7677-4d45-bb09-bd2dba6e22c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunalysis Corporation
Version Model Number220-0096
Company DUNS080589004
Company NameIMMUNALYSIS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840937100400 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-11
Device Publish Date2016-08-31

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00840937111796Immunalysis Corporation - Tapentadol Urine Calibrator - 300 ng/mL
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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
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00840937111598Immunalysis Corporation Tramadol Urine HEIA Kit 25
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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
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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
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