Pregnancy-Skreen 18000443

GUDID 00810042681088

Cardinal HCG 4mL Kit

BIOCHEMICAL DIAGNOSTICS INC

Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control
Primary Device ID00810042681088
NIH Device Record Key37f78d23-dd51-48a5-a9f2-43317050a228
Commercial Distribution StatusIn Commercial Distribution
Brand NamePregnancy-Skreen
Version Model Number18000443
Catalog Number18000443
Company DUNS028007698
Company NameBIOCHEMICAL DIAGNOSTICS INC
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 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

Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.com
Phone631-595-9200
Emailsupport@biochemicaldiagnostics.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810042681088 [Primary]
GS110810042681085 [Package]
Package: case [80 Units]
Discontinued: 2020-02-12
Not in Commercial Distribution

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-14
Device Publish Date2020-01-21

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00810042681408PREGNANCY SKREEN Custom hCG Liquid Urine 20mL
00810042681392PREGNANCY SKREEN Custom hCG Liquid Urine 5mL
00810042681385PREGNANCY SKREEN Custom hCG Liquid Urine 2mL
00810042681347PREGNANCY SKREEN Custom hCG Liquid Urine 4cc kit
00810042682900PREGNANCY SKREEN Custom hCG Serum 4mL
00810042682894PREGNANCY SKREEN Custom hCG Serum 5mL
00810042683174hCG Low Positive/Negative Urine 2x5mL Kitbox
00810042683181HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX
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