FDA.report

STAT-Site M B-HB Code Key

Primary DI
00657498000731
Brand
STAT-Site M B-HB Code Key
Company
STANBIO LABORATORY, L.P.
Model
401020
Catalog number
401020
Device description
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications

CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00657498000731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000731006574980007316574980007310657498000731

GMDN Terms

TermDefinition
Single-channel clinical chemistry analyser IVD, point-of-careA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative determination of one or multiple clinical chemistry analytes in a clinical specimen. Analytes measured include multiple clinical chemistry analytes such as glucose, ketone, specific proteins, clinical chemistry substrates, enzymes and/or a lipid profile, using a single technology such as electrometry, spectrophotometry, fluorimetry, radiometry or chemiluminescence.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius28 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags

DUNS number
045361136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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