FDA.reportPublic FDA data

Research and Diagnostic Systems

Primary DI
20815762020999
Brand
Research and Diagnostic Systems
Company
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Model
GH00NX
Catalog number
GH00NX
Device description
R&D Glu/Hgb: 3 x 1.5mL Normal Pack
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGMControl, Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGMControl, HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993321000R&D HGB/GLC WHOLE BLOOD CONTROLR&D Systems, Inc.1999-11-12GGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815762020999PrimaryGS10
00815762020995Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081576202099920815762020999
00815762020995008157620209958157620209950815762020995

GMDN Terms#

Term, Definition table
TermDefinition
Glucose/haemoglobin (Hb) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose and haemoglobin (Hb) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4.5Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-428-4246customerserviceccd@bio-techne.
800-428-4246customerserviceccd@bio-techne.com

Regulatory Flags#

DUNS number
087248183
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815762021183Research and Diagnostic SystemsPTE004PTE0042016-07-29
00815762021923Research and Diagnostic SystemsPTE5XPTE5X2016-09-13
00815762021930Research and Diagnostic SystemsPTE4XPTE4X2016-09-13
00815762021947Research and Diagnostic SystemsPTE6XPTE6X2016-09-13
00815762021954Research and Diagnostic SystemsPTE3XPTE3X2016-09-13
00815762021190Research and Diagnostic SystemsPTE006PTE0062016-07-29
00815762020490Research and Diagnostic SystemsPIX0022025-12-01
00815762023446Research and Diagnostic Systems0CP010TA32025-12-01
00815762023453Research and Diagnostic Systems0CP020TA32025-12-01
00815762021657Research and Diagnostic SystemsDTFR1DTFR12016-07-29
00815762021718Research and Diagnostic SystemsRDKAP1971RDKAP19712016-09-01
00815762021978R & D Systems, Inc. CBC-PIX Hematology ControlP0022018-12-05
00815762020131Research and Diagnostic Systems3D5043D5042016-12-20
00815762020148Research and Diagnostic Systems3D5053D5052016-12-20
00815762020155Research and Diagnostic Systems3D505T3D505T2016-12-20
00815762020223Research and Diagnostic Systems3D5183D5182016-12-20
00815762021145Research and Diagnostic SystemsLH002LH0022016-07-29
00815762021152Research and Diagnostic SystemsLH004LH0042016-07-29
00815762021282Research and Diagnostic SystemsRP401RP4012016-07-29
00815762021299Research and Diagnostic SystemsRP403RP4032016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740730716Hemoglobin MeterUrit Medical Electronic Co., Ltd.GGM2026-06-03
06935740730723Hemoglobin MeterUrit Medical Electronic Co., Ltd.GGM2026-06-03
06935740751513Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2026-06-01
06935740751520Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2026-06-01
08718734962649CueSee® CO-OXEurotrol B.V.GGM2025-01-23
08718734962656CueSee® CO-OXEurotrol B.V.GGM2025-01-23
06935740726993Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-09-20
06935740733830Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-07-12
06935740733847Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-07-12
06935740733854Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2024-07-12
04048534001557DiaSpect Control Pack HBT1DiaSpect Medical GmbHGGM2022-12-20
04048534001564DiaSpect Control Pack HBT2DiaSpect Medical GmbHGGM2022-12-20
04048534001571DiaSpect Control Pack HBT3DiaSpect Medical GmbHGGM2022-12-20
04048534001588DiaSpect Control Pack HBT4DiaSpect Medical GmbHGGM2022-12-20
08718734961024CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961048CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961550CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961567CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961574CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961581CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961598CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961000CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961062CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961079CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961086CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961604CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734962397CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961611CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734962403CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961628CueSee® CO-OXEurotrol B.V.GGM2021-12-19