FDA.reportPublic FDA data

S.G. Calibrator H

Primary DI
04987486053002
Brand
S.G. Calibrator H
Company
Arkray USA, Inc.
Model
111581
Catalog number
N/A
Device description
The S.G. Calibrator H is used for calibration of the S.G. measurement system of the AUTION system. The S.G. Calibrator establishes reference points based on the physical principles of AUTION analyzers.
Published
2025-12-19
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
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987486053002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987486053002049874860530024987486053002

GMDN Terms#

Term, Definition table
TermDefinition
Urine analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00Store in a refrigerator, avoiding exposure to light.
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
855-646-3108xx@xx.xx

Regulatory Flags#

DUNS number
008171162
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

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00015482232993TechLITE PEN NEEDLES2329292016-09-23
00015482234232TechLITE PLUS PEN NEEDLES2342322024-03-11
00015482234324TechLITE PEN NEEDLES2341322016-09-23
00015482234928TechLITE PEN NEEDLES2349322016-09-23
00015482235314TechLITE PEN NEEDLES2351312019-05-14
00015482235918TechLITE PEN NEEDLES2359312016-09-23
00015482236311TechLITE PEN NEEDLES2361312016-09-23
00015482236328TechLITE PEN NEEDLES2361322016-09-23
00015482238315TechLITE PEN NEEDLES2381312016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JMT2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JMT2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JMT2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-04-16
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.JMT2026-04-15
16936983186893DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-14
16936983192887Alltest Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192894Alltest Multi-Drug 16 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192900Alltest Multi-Drug 18 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197257Multi-Drug 8 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197264Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197271Multi-Drug 14 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16942598200619Multi-Drug 9 Drugs Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16942598203795DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-08
06942598204542Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.JMT2026-04-08
06942598216781Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.JMT2026-04-08
00677421450013NEW CHOICESCI Medic, Inc.JMT2026-03-26
00810164510624Atida Urinary Tract Infection TestACESO LABORATORIES INC.JMT2026-03-23