FDA.reportPublic FDA data

Hgb Control, Normal

Primary DI
00657498002025
Brand
Hgb Control, Normal
Company
STANBIO LABORATORY, L.P.
Model
3060-101N
Catalog number
3060-101N
Device description
A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system.
Published
2018-02-21
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498002025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498002025006574980020256574980020250657498002025

GMDN Terms#

Term, Definition table
TermDefinition
Total haemoglobin (totHb) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) 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
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
00657498002094Uri-Trak 120 M Urine AnalyzerG1300-001G1300-0012023-06-08
00657498002322HGB Controls - Low3061-0033061-0032021-03-31
00657498002339HGB Controls - Low3061-0063061-0062021-03-31
00657498002346HGB Controls - Normal3062-0033062-0032021-03-31
00657498002353HGB Controls - Normal3062-0063062-0062021-03-31
00657498002360HGB Controls - High3063-0033063-0032021-03-31
00657498002377HGB Controls - High3063-0063063-0062021-03-31
00657498001806Standard 1A469-97A469-972016-09-24
00657498000199HemoPoint H2 DMSG3500-001G3500-0012016-09-24
00657498000380Excel® Chemistry AnalyzerG7700E-001G7700E-0012018-04-17
00657498000397Excel® Chemistry Analyzer (Spanish)G7700S-001G7700S-0012018-04-17
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18

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