FDA.reportPublic FDA data

Pointe Meprobamate Calibrator (400 ng/mL) High

Primary DI
00811727018434
Brand
Pointe Meprobamate Calibrator (400 ng/mL) High
Company
POINTE SCIENTIFIC, INC.
Model
60-MB0750-5
Catalog number
60-MB0750-5
Device description
Pointe Meprobamate Calibrator (400 ng/mL) High 1 x 5 mL The Pointe Carisoprodol Metabolite (SOMA) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Carisoprodol Metabolite (SOMA) Reagent Set (Ref# 60-CM0740-100/60-CM0740-1L) on a number of automated clinical chemistry analyzers.
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DLJCalibrators, Drug Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727018434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727018434008117270184348117270184340811727018434

GMDN Terms#

Term, Definition table
TermDefinition
Carisoprodol IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of carisoprodol in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtestdx.com

Regulatory Flags#

DUNS number
045623154
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28
00811727018632Pointe Scientific CK-MBC7563-30C7563-302021-02-28
00811727018649Pointe Scientific CK-MBC7563-90C7563-902021-02-28
00811727014139Pointe G6PD ReagentG7583-180G7583-1802021-01-30
00811727015594Pointe Lipoprotein (a) Control SetL7597-CTLL7597-CTL2021-01-30
00811727015679Pointe G6PD ControlsG7583-CTLG7583-CTL2021-01-30
00811727015815Pointe CRP Reagent14-C7568-48014-C7568-4802021-01-30
00811727015891Pointe Lactate Reagent 14-L7596-38014-L7596-3802021-01-30
00811727015907Pointe Lactate Dehydrogenase Reagent14-L7572-20014-L7572-2002021-01-30

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